Liver TransplantationNCT05589441
Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation
A study testing salbutamol and Insulin in people with Liver Transplantation, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The therapeutic effect of nebulized salbutamol on hyperkalemia during reperfusion in liver transplantation patients. Secondary research objectives: To observe the results of blood gas analysis, changes in urinary potassium and hemodynamic parameters, and the incidence of reperfusion syndrome in liver transplantation… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- salbutamol and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2022to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 70 years old;
- Cardiac function grades I to III (NYHA standard);
- Plan to undergo orthotopic liver transplantation;
- Serum potassium ion concentration greater than 4 mmol/h at the beginning of anhepatic phase;
- Those who are willing to sign the informed consent form.
Who cannot join
- Intraoperative CRRT patients;
- Those who are allergic to the test drug;
- refuse to join the trial investigator;
- Patients who are participating in other clinical trials, the researchers believe that other reasons are not suitable for clinical trials.
- Anyone with any of the above conditions cannot be selected for this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation: a Single-center, Randomized, Positive-controlled Clinical Study
The therapeutic effect of nebulized salbutamol on hyperkalemia during reperfusion in liver transplantation patients. Secondary research objectives: To observe the results of blood gas analysis, changes in urinary potassium and hemodynamic parameters, and the incidence of reperfusion syndrome in liver transplantation, and to observe the incidence of postoperative pulmonary complications during the 7-day follow-up. To explore the effect of aerosol inhalation of salbutamol on new liver reperfusion syndrome in patients with liver transplantation, and to provide a theoretical basis for clinical treatment.
Read the detailed description
- Research background 1.1 Study disease Hyperkalemia during reperfusion in patients with end-stage liver disease undergoing liver transplantation 1.2 Research status at home and abroad 1.2.1 Hyperkalemia in the perioperative period of liver transplantation and hyperkalemia caused by DCD donor liver Hyperkalemia refers to a state in which the concentration of potassium ions in the patient;s serum exceeds 5 mmol/L.Clinical symptoms include muscle twitches, spasms, weakness, ascending paralysis, ECG changes, and heart rhythm. Severe hyperkalemia can be life-threatening in the form of abnormalities. Hyperkalemia is a common complication in orthotopic liver transplantation. Immediate blood potassium in new liver reperfusion can be as high as 7 mmol/L to 8 mmol/L. Especially in patients with renal insufficiency, the clinical manifestations are more dangerous, which can lead to serious complications. Arrhythmias and even cardiac arrest. There are several reasons for the occurrence of hyperkalemia during liver transplantation: 1. Severe metabolic acidosis in the anhepatic phase, resulting in increased H+-K+ exchange on the cell membrane; 2. Poor coagulation function in patients undergoing liver transplantation, Intraoperative red blood cell transfusion volume is large, resulting in the increase of exogenous potassium ions; 3 UW organ protection solution for liver transplantation contains a large amount of potassium ions, which enter the blood circulation after reperfusion, resulting in post-reperfusion hyperkalemia . Since January 1, 2015, organ donation after the death of a citizen (DCD) has become the only legal source of organ transplant donors in China. Recent studies have shown that DCD donors are the main source of hyperkalemia after liver transplant reperfusion. This is an independent risk factor for liver disease, which is due to the long warm ischemia time in the liver of DCD donors, and the hypoxic injury of hepatocytes is more serious, and the damage of oxygen free radicals after reperfusion will cause potassium ions to be released from hepatocytes. Under this circumstance, it is particularly important to prevent and treat hyperkalemia after reperfusion to ensure the safety of perioperative anesthesia in patients with liver transplantation. 1.2.2 Treatment of hyperkalemia At present, the methods of treating hyperkalemia routinely used in clinic are as follows: 1 Membrane stabilizer Commonly used are calcium gluconate and calcium chloride. Hyperkalemia increases the action potential threshold of cardiomyocytes and causes myocardial membrane instability. Calcium ions can counteract this situation by restoring the transmembrane voltage gradient of cardiomyocytes and reduce the toxicity of cardiomyocytes caused by hyperkalemia. 2 To promote the excretion of potassium ions The most commonly used are the use of diuretics, hemodialysis, potassium-lowering resin. 3 Redistribution of potassium ions in and out of cells Insulin combined with glucose infusion, nebulized inhalation or intravenous salbutamol. However, not every method is suitable for liver transplantation. Intravenous calcium injection can stabilize the cell membrane against the toxic effect of high potassium on the myocardium, but it cannot reduce the serum potassium ion concentration, and there is a risk of bradycardia. Side effects: Most patients with end-stage liver disease have hepatorenal syndrome, and the effect of diuretics is limited, and after extensive use, it will aggravate the occurrence of cellular metabolic acidosis, and even increase serum potassium. Hemodialysis is one of the most effective treatments for hyperkalemia, but its use is limited in liver transplantation, and a dialysis pipeline needs to be established in advance, and the use of heparin during dialysis to prevent thrombosis in the pipeline will affect the coagulation function of patients and cause intraoperative complications. Bleeding increases and is less used in liver transplantation; potassium-lowering resin has a slow onset and limited effect, and needs to be taken from the gastrointestinal tract and cannot be used in liver transplantation; patients with end-stage liver disease usually have insulin resistance;, Intravenous infusion of insulin compounded with glucose, the dose of administration is difficult to control, the therapeutic effect is unreliable, and it is easy to cause severe fluctuations in the blood glucose level of patients during the perioperative period. Studies have found that salbutamol can transport potassium ions in serum to liver cells and skeletal muscle cells by activating sodium-potassium-ATPase and NKCC1 Na+-K+-2Cl- co-transporter, thereby reducing serum potassium ion concentration. 1.2.3 The application prospect of nebulized salbutamol in the perioperative period of liver transplantation Salbutamol is an adrenergic β-receptor agonist, because it can selectively stimulate the β2-receptor of bronchial smooth muscle, it is a strong bronchodilator, and it is mainly used in the clinical prevention and treatment of bronchial asthma or asthmatic bronchitis , improve the patient ventilation function. Recent studies found that salbutamol can transport potassium ions in serum to liver cells and skeletal muscle cells by activating sodium-potassium-ATPase and NKCC1 Na+-K+-2Cl- co-transporters, reducing serum potassium ions. concentration. Among them, there are two kinds of administration modes of salbutamol: intravenous injection and atomization inhalation, among which the method of atomization inhalation has good effect and small side effects. In patients with end-stage renal disease and hyperkalemia, the serum potassium ion concentration decreased by 0.6 mmol/L 30 minutes after inhalation of 10 mg of salbutamol, and decreased by 1 mmol/L one hour later. However, there is no report on its application in the treatment of hyperkalemia during reperfusion of liver transplantation. All liver transplantation operations are performed under general anesthesia with endotracheal intubation. It is small, convenient and easy to operate, and intraoperative atomized inhalation of salbutamol can also stimulate β receptors, increase heart rate, and resist the occurrence of reperfusion syndrome, which has good research opportunities and clinical application value. 1.3 Preliminary research results of the project team The investigators liver transplantation anesthesia team has now conducted a preliminary experiment in 10 cases of liver transplantation by inhalation of salbutamol before the anhepatic phase. The concentration of serum potassium can be significantly reduced 30 minutes after inhalation. The data are as follows: Items 5min before inhalation(Blood potassium:4.35±0.26mmol/L 5min after inhalation(Blood potassium:4.34±0.30mmol/L 10min after inhalation(Blood potassium:4.15±0.33mmol/L 15min after inhalation(Blood potassium:4.05±0.29mmol/L 30min after inhalation(Blood potassium:3.6±0.31mmol/L 45min after inhalation(Blood potassium:3.25±0.41mmol/L 30s after reperfusion(Blood potassium:5.21±0.68mmol/L 5 min after reperfusion(Blood potassium:3.91±0.55mmol/L 30min after reperfusion(Blood potassium:3.53±0.49mmol/L (mmol/L)
- Research objectives 2.1 Main research objectives To observe the effect of nebulized inhalation of salbutamol in the treatment of hyperkalemia during liver transplantation and reperfusion 2.2 Secondary research objectives and exploratory research objectives The changes in blood gas, urine potassium and hemodynamic parameters during surgery in liver transplant patients were observed, and the incidence of postoperative complications was observed 7 days after surgery. To explore the effect of nebulized inhalation of salbutamol on liver transplant patients on intraoperative reperfusion syndrome and postoperative lung complications, and to provide a theoretical basis for clinical treatment.
- Research Overview 3.1 Study Type Randomized, double-blind, parallel controlled clinical trial Single-centered, prospective, randomized, controlled studies Single Center: The First Affiliated Hospital of Jiaotong University Random: Generate a random grouping table by a random program. Make sealed envelopes with random information based on random grouping tables. Pay attention to age, sex, ASA grade, and surgeon balance at random. After the patient is selected and randomized, open the envelope according to the corresponding random number to obtain the random number.
Positive controls: nebulized inhalation of salbutamol group and insulin complex glucose group in two groups.
- Conditions
- Liver Transplantation
- Being tested
- salbutamol, Insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
Also called Nebulized inhalation of salbutamol
10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase.
InsulinDrug
Also called Insulin complex glucose group
Intravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized inhalation of salbutamol group | Experimental | 10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase. Receives: Drug: salbutamol |
| Insulin complex glucose group | Experimental | Intravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 5 minutes before treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 5 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 10 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 15 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 30 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 45 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 60 minutes after treatment
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 30 seconds after reperfusion
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 5 minutes after reperfusion
Blood potassium concentration,mmol/L
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Measured: measured blood gas at 30 minutes after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start28 Oct 2022 (estimated)
- Primary completion10 Oct 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Wen, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589441
- Sponsor's protocol ID
- XJTU1AF-CRF-2019-021
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical Study Data and Results
Publications
Ding Y, Wen J, Xiao Y. Comparison of nebulized salbutamol and glucose-insulin for preventing acute hyperkalemia in liver transplantation: a randomized, double-blind trial. J Anesth. 2026 Aug;40(4):585-594. doi: 10.1007/s00540-025-03643-2. Epub 2026 Jan 21.
PubMed 41565838
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation: a Single-center, Randomized, Positive-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05589441
- Acronym / sponsor ID
- XJTU1AF-CRF-2019-021
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 28 Oct 2022 (estimated)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The therapeutic effect of nebulized salbutamol on hyperkalemia during reperfusion in liver transplantation patients. Secondary research objectives: To observe the results of blood gas analysis, changes in urinary potassium and hemodynamic parameters, and the incidence of reperfusion syndrome in liver transplantation, and to observe the incidence of postoperative pulmonary complications during the 7-day follow-up. To explore the effect of aerosol inhalation of salbutamol on new liver reperfusion syndrome in patients with liver transplantation, and to provide a theoretical basis for clinical treatment.
Detailed description
- Research background 1.1 Study disease Hyperkalemia during reperfusion in patients with end-stage liver disease undergoing liver transplantation 1.2 Research status at home and abroad 1.2.1 Hyperkalemia in the perioperative period of liver transplantation and hyperkalemia caused by DCD donor liver Hyperkalemia refers to a state in which the concentration of potassium ions in the patient;s serum exceeds 5 mmol/L.Clinical symptoms include muscle twitches, spasms, weakness, ascending paralysis, ECG changes, and heart rhythm. Severe hyperkalemia can be life-threatening in the form of abnormalities. Hyperkalemia is a common complication in orthotopic liver transplantation. Immediate blood potassium in new liver reperfusion can be as high as 7 mmol/L to 8 mmol/L. Especially in patients with renal insufficiency, the clinical manifestations are more dangerous, which can lead to serious complications. Arrhythmias and even cardiac arrest. There are several reasons for the occurrence of hyperkalemia during liver transplantation: 1. Severe metabolic acidosis in the anhepatic phase, resulting in increased H+-K+ exchange on the cell membrane; 2. Poor coagulation function in patients undergoing liver transplantation, Intraoperative red blood cell transfusion volume is large, resulting in the increase of exogenous potassium ions; 3 UW organ protection solution for liver transplantation contains a large amount of potassium ions, which enter the blood circulation after reperfusion, resulting in post-reperfusion hyperkalemia . Since January 1, 2015, organ donation after the death of a citizen (DCD) has become the only legal source of organ transplant donors in China. Recent studies have shown that DCD donors are the main source of hyperkalemia after liver transplant reperfusion. This is an independent risk factor for liver disease, which is due to the long warm ischemia time in the liver of DCD donors, and the hypoxic injury of hepatocytes is more serious, and the damage of oxygen free radicals after reperfusion will cause potassium ions to be released from hepatocytes. Under this circumstance, it is particularly important to prevent and treat hyperkalemia after reperfusion to ensure the safety of perioperative anesthesia in patients with liver transplantation. 1.2.2 Treatment of hyperkalemia At present, the methods of treating hyperkalemia routinely used in clinic are as follows: 1 Membrane stabilizer Commonly used are calcium gluconate and calcium chloride. Hyperkalemia increases the action potential threshold of cardiomyocytes and causes myocardial membrane instability. Calcium ions can counteract this situation by restoring the transmembrane voltage gradient of cardiomyocytes and reduce the toxicity of cardiomyocytes caused by hyperkalemia. 2 To promote the excretion of potassium ions The most commonly used are the use of diuretics, hemodialysis, potassium-lowering resin. 3 Redistribution of potassium ions in and out of cells Insulin combined with glucose infusion, nebulized inhalation or intravenous salbutamol. However, not every method is suitable for liver transplantation. Intravenous calcium injection can stabilize the cell membrane against the toxic effect of high potassium on the myocardium, but it cannot reduce the serum potassium ion concentration, and there is a risk of bradycardia. Side effects: Most patients with end-stage liver disease have hepatorenal syndrome, and the effect of diuretics is limited, and after extensive use, it will aggravate the occurrence of cellular metabolic acidosis, and even increase serum potassium. Hemodialysis is one of the most effective treatments for hyperkalemia, but its use is limited in liver transplantation, and a dialysis pipeline needs to be established in advance, and the use of heparin during dialysis to prevent thrombosis in the pipeline will affect the coagulation function of patients and cause intraoperative complications. Bleeding increases and is less used in liver transplantation; potassium-lowering resin has a slow onset and limited effect, and needs to be taken from the gastrointestinal tract and cannot be used in liver transplantation; patients with end-stage liver disease usually have insulin resistance;, Intravenous infusion of insulin compounded with glucose, the dose of administration is difficult to control, the therapeutic effect is unreliable, and it is easy to cause severe fluctuations in the blood glucose level of patients during the perioperative period. Studies have found that salbutamol can transport potassium ions in serum to liver cells and skeletal muscle cells by activating sodium-potassium-ATPase and NKCC1 Na+-K+-2Cl- co-transporter, thereby reducing serum potassium ion concentration. 1.2.3 The application prospect of nebulized salbutamol in the perioperative period of liver transplantation Salbutamol is an adrenergic β-receptor agonist, because it can selectively stimulate the β2-receptor of bronchial smooth muscle, it is a strong bronchodilator, and it is mainly used in the clinical prevention and treatment of bronchial asthma or asthmatic bronchitis , improve the patient ventilation function. Recent studies found that salbutamol can transport potassium ions in serum to liver cells and skeletal muscle cells by activating sodium-potassium-ATPase and NKCC1 Na+-K+-2Cl- co-transporters, reducing serum potassium ions. concentration. Among them, there are two kinds of administration modes of salbutamol: intravenous injection and atomization inhalation, among which the method of atomization inhalation has good effect and small side effects. In patients with end-stage renal disease and hyperkalemia, the serum potassium ion concentration decreased by 0.6 mmol/L 30 minutes after inhalation of 10 mg of salbutamol, and decreased by 1 mmol/L one hour later. However, there is no report on its application in the treatment of hyperkalemia during reperfusion of liver transplantation. All liver transplantation operations are performed under general anesthesia with endotracheal intubation. It is small, convenient and easy to operate, and intraoperative atomized inhalation of salbutamol can also stimulate β receptors, increase heart rate, and resist the occurrence of reperfusion syndrome, which has good research opportunities and clinical application value. 1.3 Preliminary research results of the project team The investigators liver transplantation anesthesia team has now conducted a preliminary experiment in 10 cases of liver transplantation by inhalation of salbutamol before the anhepatic phase. The concentration of serum potassium can be significantly reduced 30 minutes after inhalation. The data are as follows: Items 5min before inhalation(Blood potassium:4.35±0.26mmol/L 5min after inhalation(Blood potassium:4.34±0.30mmol/L 10min after inhalation(Blood potassium:4.15±0.33mmol/L 15min after inhalation(Blood potassium:4.05±0.29mmol/L 30min after inhalation(Blood potassium:3.6±0.31mmol/L 45min after inhalation(Blood potassium:3.25±0.41mmol/L 30s after reperfusion(Blood potassium:5.21±0.68mmol/L 5 min after reperfusion(Blood potassium:3.91±0.55mmol/L 30min after reperfusion(Blood potassium:3.53±0.49mmol/L (mmol/L)
- Research objectives 2.1 Main research objectives To observe the effect of nebulized inhalation of salbutamol in the treatment of hyperkalemia during liver transplantation and reperfusion 2.2 Secondary research objectives and exploratory research objectives The changes in blood gas, urine potassium and hemodynamic parameters during surgery in liver transplant patients were observed, and the incidence of postoperative complications was observed 7 days after surgery. To explore the effect of nebulized inhalation of salbutamol on liver transplant patients on intraoperative reperfusion syndrome and postoperative lung complications, and to provide a theoretical basis for clinical treatment.
- Research Overview 3.1 Study Type Randomized, double-blind, parallel controlled clinical trial Single-centered, prospective, randomized, controlled studies Single Center: The First Affiliated Hospital of Jiaotong University Random: Generate a random grouping table by a random program. Make sealed envelopes with random information based on random grouping tables. Pay attention to age, sex, ASA grade, and surgeon balance at random. After the patient is selected and randomized, open the envelope according to the corresponding random number to obtain the random number.
Positive controls: nebulized inhalation of salbutamol group and insulin complex glucose group in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized inhalation of salbutamol group | Experimental | Drug: salbutamol10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase. |
| Insulin complex glucose group | Experimental | Drug: InsulinIntravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 to 70 years old;
- Cardiac function grades I to III (NYHA standard);
- Plan to undergo orthotopic liver transplantation;
- Serum potassium ion concentration greater than 4 mmol/h at the beginning of anhepatic phase;
- Those who are willing to sign the informed consent form.
Key exclusion criteria (5 listed)
- Intraoperative CRRT patients;
- Those who are allergic to the test drug;
- refuse to join the trial investigator;
- Patients who are participating in other clinical trials, the researchers believe that other reasons are not suitable for clinical trials.
- Anyone with any of the above conditions cannot be selected for this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salbutamolAlso: Nebulized inhalation of salbutamol10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase. | Drug | Nebulized inhalation of salbutamol group |
| InsulinAlso: Insulin complex glucose groupIntravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes. | Drug | Insulin complex glucose group |
Primary outcome
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 5 minutes before treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 5 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 10 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 15 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 30 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 45 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 60 minutes after treatment
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 30 seconds after reperfusion
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 5 minutes after reperfusion
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Blood potassium concentration,mmol/L
Time frame: measured blood gas at 30 minutes after reperfusion
Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 41565838Ding Y, Wen J, Xiao Y. Comparison of nebulized salbutamol and glucose-insulin for preventing acute hyperkalemia in liver transplantation: a randomized, double-blind trial. J Anesth. 2026 Aug;40(4):585-594. doi: 10.1007/s00540-025-03643-2. Epub 2026 Jan 21.
- Individual participant dataSharing planned: No. Clinical Study Data and Results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Wen, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing salbutamol and Insulin in people with Liver Transplantation, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wang, PhD (18049286968 ext. 0086-, dr.wangqiang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood potassium concentration,mmol/L (time frame: measured blood gas at 5 minutes before treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.