Acute Kidney InjuryNCT04302467
Effects of Intraoperative Fluid Therapy on Acute Kidney Injury After Thoracoscopic Lobectomy
A study testing fluid therapy during operation in people with Acute Kidney Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- fluid therapy during operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: patients comply any of the following criteria will be enrolled
- Age>70 years old
- Forced expiratory volume in 1 second (FEV1)<60%
- Carbon monoxide lung diffusion capacity (DLCO)<60%
- History of coronary artery disease
Exclusion Criteria: patients comply any of the following criteria may not be enrolled
- Patients refused
- Creatinine>176 μmol/L, and/or BUN>7.1 mmol/L
- NT-proBNP>300 ng/L
- Systemic or local infection
- Albumin<30 g/L, and/or Hemoglobin<100 g/L
- Allergy to hydroxyethyl starch
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Effects of Goal-directed Fluid Therapy and Restrictive Fluid Therapy During Operation Combined With Enhanced Recovery After Surgery Protocol on Acute Kidney Injury After Thoracoscopic Lobectomy in High Risk Patients
Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) integrates a range of perioperative interventions to decrease postoperative complications after surgery. In ERAS protocol of lobectomy, restrictive fluid therapy during operation is recommended. In this study, the investigators will compare the effects of GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients.
Methods/design: This is prospective single-center single-blind randomized controlled trial. 276 patients scheduled to undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block are randomly divided into GDFT group and restrictive fluid therapy group at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes are (1) the incidence of renal replacement therapy, (2) length of intensive care unit (ICU) stay after operation, (3) length of hospital stay after operation , (4) incidence of other complications including: infection, acute lung injury (ALI), pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery (MINS), cardiac infarction.
Discussion: This is the first study to compare GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. The investigators expected that the two methods have the same effect on the incidence of AKI, but restrictive fluid therapy is simpler to applied than GDFT.
Read the detailed description
Participants: Patients aged more than 18 years old who are scheduled to undergo thoracoscopic lobectomy well be enrolled in this trial. Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. Participants will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.
Interventions: All participants will start lung function exercise, quit smoking, reinforce nutrition after hospitalization. Participants will fast for 6 hours and prohibit of drinking water for 2 hours before operation. Antibiotic will be used 1 hour before operation. No premedication will be administered to the patients. The electrocardiography (ECG), pulse oximetry, invasive arterial blood pressure, nasopharyngeal temperature, and bispectral index monitoring will be instituted. Urinary catheter will be inserted after anesthesia and removed immediately after operation. Patients will undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block. General anesthesia will be inducted with sufentanil, propofol, and rocuronium, and maintained with continuous infusion of propofol and remifentanil, intermittent injection of rocuronium. Lung-protective ventilation strategy will be used during mechanical ventilation. Recovery from general anesthesia as quickly as possible. Paravertebral block will be performed under the guidance of ultrasound after general anesthesia induction. Paravertebral block, patient controlled analgesia and oral analgesics will be used for postoperative analgesia. Recovering of oral rehydration, eating and getting out of bed as early as possible.
In GDFT group, the arterial catheter will be connected with FloTrac/Vigileo sensor (Edwards lifesciences, Irvine, CA, USA), The stroke volume variation (SVV) and cardiac index (CI) will be monitored. Fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV<13%, but mean arterial pressure (MAP)<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min.
In restrictive fluid therapy group, fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP>65 mmHg.
Measurements: The primary outcome is the incidence of AKI after operation. The secondary outcomes include: (1) Incidence of renal replacement therapy, (2) Length of ICU stay after operation, (3) Length of hospital stay after operation, (4) Incidence of other complications including: infection, ALI, pneumonia, arrhythmia, heart failure, MINS, cardiac infarction.
Sample size: The primary outcome of this trial is the incidence of AKI after operation. Another study showed that the incidence of AKI was 4% and 2.9% in liberal infusion and GDFT respectively, the efficacy of intervention was 27.5%. Investigators hypothesis that restrictive fluid therapy combined with ERAS protocol has the same therapeutic effect as GDFT. The sample size for this study was calculated to achieve a statistical power of 0.8 and alpha error of 0.05 using a two-sided test. Considering a dropout rate of 10%, 138 patients are required in each group.
Statistical analysis: Normally distributed data will be presented as the mean±standard deviation. Categorical data will be presented as the number and the percentage of patients. The primary outcome (the incidence of AKI after operation) will be compared between the two groups with Pearson's chi-square test. The secondary outcomes will be compared between the two groups with independent-samples Student's t-tests for normally distributed continuous data and Pearson's chi-square test for categorical data. All statistical test are two-sided, and a P-value <0.05 will be considered statistically significant.
- Conditions
- Acute Kidney Injury
- Being tested
- fluid therapy during operation
- Keywords
- Acute kidney injury, Goal-directed fluid therapy, Enhanced recovery after surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid therapy during operationProcedure or surgery
Also called Implement ERAS protocol of lobectomy during perioperation
ERAS protocol of lobectomy will implemented to all the participants during perioperation,two groups of participants will be given different intraoperative fluid therapy strategy.
| Study group | Role | What they receive |
|---|---|---|
| GDFT group | Experimental | Fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV<13%, but mean arterial pressure (MAP)<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min. Receives: Procedure: fluid therapy during operation |
| restrictive fluid therapy group | Experimental | fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP>65 mmHg. Receives: Procedure: fluid therapy during operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with acute kidney injury
50% relative or 0.3 mg/dl (26.5 μmol/L) absolute increase in creatinine over the preoperative value during the first two postoperative days.
Measured: 48 hours after operation
Secondary outcomes (10)
number of participants in need of renal replacement therapy
Patients who need renal replacement therapy, the indications of renal replacement therapy will be determined by clinician
Measured: 30 days after operation
length of ICU stay after operation
from the end of operation to ICU discharge
Measured: 30 days after operation
length of hospital stay after operation
from the end of operation to discharge
Measured: 30 days after operation
number of participants with infection
Patients with postoperative infection, including: wound infection, urinary tract infection, systemic infection
Measured: 30 days after operation
number of participants with acute lung injury
Oxygen partial pressure/fraction of inhaled oxygen(PaO2/FiO2)<300 mmHg 24 hours after operation, bilateral lung infiltration, exclude cardiogenic pulmonary edema.
Measured: 24 hours after operation
number of participants with pneumonia
new or progressive and persistent infiltrates, consolidation, cavitation. And at least one of the following: (1) fever (>38℃) with no other recognised cause, (2) white cell count<4×109/L or >12×109/L, (3) altered mental status with no other recognised cause for patients more than 70 years old. And at least two of the following:(1) new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements, (2) new onset or worsening cough, or dyspnea, or tachypnea, (3) rales or bronchial breath sounds, (4) worse gas exchange.
Measured: 30 days after operation
number of participants with arrhythmia
patients who have new-onset arrhythmia 48 hours after operation
Measured: 48 hours after operation
number of participants with heart failure
NT-proBNP is more than 450 ng/L if age less than 50, or NT-proBNP is more than 900 ng/L if age more than 50.
Measured: 48 hours after operation
number of participants with myocardial injury after noncardiac surgery
troponin T is more than 0.03 ng/ml and/or creatine kinase-MB is more than 8.8 ng/ml.
Measured: 7 days after operation
number of participants with cardiac infarction
troponin T elevation in the presence of at least one of ischemic symptoms: (1) the development of new or presumed new Q waves, (2) ST segment or T wave changes, (3) left bundle branch block on ECG, (4) a new or presumed new regional wall motion abnormality on echocardiography.
Measured: 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 May 2020
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. They will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng Guan, MD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302467
- Sponsor's protocol ID
- XJTU1AF-CRF-2019-012
- Status last verified
- Aug 2021
- First submitted
- 26 Feb 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' private information will not be collected. Only the study code will be collected. The data collected will be kept confidential until they are required for analysis. The data collected will be stored under encryption for 2 years after the completion of the study.
Publications
Ma H, Li X, Wang Z, Qiao Q, Gao Y, Yuan H, Guan B, Guan Z. The effect of intraoperative goal-directed fluid therapy combined with enhanced recovery after surgery program on postoperative complications in elderly patients undergoing thoracoscopic pulmonary resection: a prospective randomized controlled study. Perioper Med (Lond). 2023 Jul 10;12(1):33. doi: 10.1186/s13741-023-00327-x.
PubMed 37430359Guan Z, Gao Y, Qiao Q, Wang Q, Liu J. Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial. Trials. 2021 Jan 7;22(1):36. doi: 10.1186/s13063-020-04983-y.
PubMed 33413593
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Goal-directed Fluid Therapy and Restrictive Fluid Therapy During Operation Combined With Enhanced Recovery After Surgery Protocol on Acute Kidney Injury After Thoracoscopic Lobectomy in High Risk Patients
- ClinicalTrials.gov ID
- NCT04302467
- Acronym / sponsor ID
- XJTU1AF-CRF-2019-012
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Goal-directed fluid therapy, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 10 Mar 2020 (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.
Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) integrates a range of perioperative interventions to decrease postoperative complications after surgery. In ERAS protocol of lobectomy, restrictive fluid therapy during operation is recommended. In this study, the investigators will compare the effects of GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients.
Methods/design: This is prospective single-center single-blind randomized controlled trial. 276 patients scheduled to undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block are randomly divided into GDFT group and restrictive fluid therapy group at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes are (1) the incidence of renal replacement therapy, (2) length of intensive care unit (ICU) stay after operation, (3) length of hospital stay after operation , (4) incidence of other complications including: infection, acute lung injury (ALI), pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery (MINS), cardiac infarction.
Discussion: This is the first study to compare GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. The investigators expected that the two methods have the same effect on the incidence of AKI, but restrictive fluid therapy is simpler to applied than GDFT.
Detailed description
Participants: Patients aged more than 18 years old who are scheduled to undergo thoracoscopic lobectomy well be enrolled in this trial. Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. Participants will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.
Interventions: All participants will start lung function exercise, quit smoking, reinforce nutrition after hospitalization. Participants will fast for 6 hours and prohibit of drinking water for 2 hours before operation. Antibiotic will be used 1 hour before operation. No premedication will be administered to the patients. The electrocardiography (ECG), pulse oximetry, invasive arterial blood pressure, nasopharyngeal temperature, and bispectral index monitoring will be instituted. Urinary catheter will be inserted after anesthesia and removed immediately after operation. Patients will undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block. General anesthesia will be inducted with sufentanil, propofol, and rocuronium, and maintained with continuous infusion of propofol and remifentanil, intermittent injection of rocuronium. Lung-protective ventilation strategy will be used during mechanical ventilation. Recovery from general anesthesia as quickly as possible. Paravertebral block will be performed under the guidance of ultrasound after general anesthesia induction. Paravertebral block, patient controlled analgesia and oral analgesics will be used for postoperative analgesia. Recovering of oral rehydration, eating and getting out of bed as early as possible.
In GDFT group, the arterial catheter will be connected with FloTrac/Vigileo sensor (Edwards lifesciences, Irvine, CA, USA), The stroke volume variation (SVV) and cardiac index (CI) will be monitored. Fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV<13%, but mean arterial pressure (MAP)<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min.
In restrictive fluid therapy group, fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP>65 mmHg.
Measurements: The primary outcome is the incidence of AKI after operation. The secondary outcomes include: (1) Incidence of renal replacement therapy, (2) Length of ICU stay after operation, (3) Length of hospital stay after operation, (4) Incidence of other complications including: infection, ALI, pneumonia, arrhythmia, heart failure, MINS, cardiac infarction.
Sample size: The primary outcome of this trial is the incidence of AKI after operation. Another study showed that the incidence of AKI was 4% and 2.9% in liberal infusion and GDFT respectively, the efficacy of intervention was 27.5%. Investigators hypothesis that restrictive fluid therapy combined with ERAS protocol has the same therapeutic effect as GDFT. The sample size for this study was calculated to achieve a statistical power of 0.8 and alpha error of 0.05 using a two-sided test. Considering a dropout rate of 10%, 138 patients are required in each group.
Statistical analysis: Normally distributed data will be presented as the mean±standard deviation. Categorical data will be presented as the number and the percentage of patients. The primary outcome (the incidence of AKI after operation) will be compared between the two groups with Pearson's chi-square test. The secondary outcomes will be compared between the two groups with independent-samples Student's t-tests for normally distributed continuous data and Pearson's chi-square test for categorical data. All statistical test are two-sided, and a P-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. They will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.
| Arm | Type | Receives |
|---|---|---|
| GDFT group | Experimental | Procedure: fluid therapy during operationFluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV<13%, but mean arterial pressure (MAP)<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min. |
| restrictive fluid therapy group | Experimental | Procedure: fluid therapy during operationfluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP>65 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fluid therapy during operationAlso: Implement ERAS protocol of lobectomy during perioperationERAS protocol of lobectomy will implemented to all the participants during perioperation,two groups of participants will be given different intraoperative fluid therapy strategy. | Procedure or surgery | GDFT group, restrictive fluid therapy group |
Primary outcome
number of participants with acute kidney injury
Time frame: 48 hours after operation
50% relative or 0.3 mg/dl (26.5 μmol/L) absolute increase in creatinine over the preoperative value during the first two postoperative days.
10 secondary outcomes
number of participants in need of renal replacement therapy
Time frame: 30 days after operation
length of ICU stay after operation
Time frame: 30 days after operation
length of hospital stay after operation
Time frame: 30 days after operation
number of participants with infection
Time frame: 30 days after operation
number of participants with acute lung injury
Time frame: 24 hours after operation
number of participants with pneumonia
Time frame: 30 days after operation
number of participants with arrhythmia
Time frame: 48 hours after operation
number of participants with heart failure
Time frame: 48 hours after operation
number of participants with myocardial injury after noncardiac surgery
Time frame: 7 days after operation
number of participants with cardiac infarction
Time frame: 48 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 37430359Ma H, Li X, Wang Z, Qiao Q, Gao Y, Yuan H, Guan B, Guan Z. The effect of intraoperative goal-directed fluid therapy combined with enhanced recovery after surgery program on postoperative complications in elderly patients undergoing thoracoscopic pulmonary resection: a prospective randomized controlled study. Perioper Med (Lond). 2023 Jul 10;12(1):33. doi: 10.1186/s13741-023-00327-x.
- Derived from this study: PubMed 33413593Guan Z, Gao Y, Qiao Q, Wang Q, Liu J. Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial. Trials. 2021 Jan 7;22(1):36. doi: 10.1186/s13063-020-04983-y.
- Individual participant dataSharing planned: No. Participants' private information will not be collected. Only the study code will be collected. The data collected will be kept confidential until they are required for analysis. The data collected will be stored under encryption for 2 years after the completion of the study.
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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.
Zheng Guan, MD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid therapy during operation in people with Acute Kidney Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with acute kidney injury (time frame: 48 hours after operation). 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 NCT04302467, which also lists 2 linked publications.
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 1 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.