Valvular Heart DiseaseNCT01825720
Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
A study testing (Glucose-Insulin-Potassium)GIK group and normal saline group in people with Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- (Glucose-Insulin-Potassium)GIK group and normal saline group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to May 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:
- congestive heart failure
- infective endocarditis
- redo valvular surgery
- surgery combined with coronary bypass graft
- multiple valvular surgery
- expected CPB duration longer than 2 hr 7> preoperative serum creatinine over 1.4 mg/dl 8> preoperative hemoglobin level less than 12 mg/dl 9> left ventricular ejection fraction less than 40%
Who cannot join
- emergency surgery
- hemodynamic instability before surgery (mean arterial pressure < 60 mmHg, heart rate >100 /min
- need for pharmacological or mechanical assist for hemodynamic stability before surgery
- baseline blood lactate level more than 2 mmol/l
- on steroid or NSAID
- hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Seoul, Seoul, 120-752
About this study
Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.
- Conditions
- Valvular Heart Disease
- Being tested
- (Glucose-Insulin-Potassium)GIK group, normal saline group
- Keywords
- GIK, valvular heart surgery, lactate
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Glucose-Insulin-Potassium)GIK groupDrug
infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery
normal saline groupDrug
same rate of normal saline
| Study group | Role | What they receive |
|---|---|---|
| (Glucose-Insulin-Potassium)GIK group | Experimental | infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery Receives: Drug: (Glucose-Insulin-Potassium)GIK group |
| normal saline group | Active comparator | same rate of normal saline Receives: Drug: normal saline group |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative blood lactate level
Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group
Measured: change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
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 Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825720
- Sponsor's protocol ID
- 4-2012-0347
- Status last verified
- Oct 2013
- First submitted
- 26 Mar 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Roh GU, Shim JK, Song JW, Kang HM, Kwak YL. Effect of glucose-insulin-potassium on hyperlactataemia in patients undergoing valvular heart surgery: A randomised controlled study. Eur J Anaesthesiol. 2015 Aug;32(8):555-62. doi: 10.1097/EJA.0000000000000250.
PubMed 25760680
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT01825720
- Acronym / sponsor ID
- 4-2012-0347
- Conditions
- Valvular Heart Disease
- Keywords
- GIK, valvular heart surgery, lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Apr 2013 (estimated)
- 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.
Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Glucose-Insulin-Potassium)GIK group | Experimental | Drug: (Glucose-Insulin-Potassium)GIK groupinfusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery |
| normal saline group | Active comparator | Drug: normal saline groupsame rate of normal saline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:
Key exclusion criteria (6 listed)
- emergency surgery
- hemodynamic instability before surgery (mean arterial pressure < 60 mmHg, heart rate >100 /min
- need for pharmacological or mechanical assist for hemodynamic stability before surgery
- baseline blood lactate level more than 2 mmol/l
- on steroid or NSAID
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 |
|---|---|---|
| (Glucose-Insulin-Potassium)GIK groupinfusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery | Drug | (Glucose-Insulin-Potassium)GIK group |
| normal saline groupsame rate of normal saline | Drug | normal saline group |
Primary outcome
perioperative blood lactate level
Time frame: change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1)
Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group
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 11 Oct 2013.
- Derived from this study: PubMed 25760680Roh GU, Shim JK, Song JW, Kang HM, Kwak YL. Effect of glucose-insulin-potassium on hyperlactataemia in patients undergoing valvular heart surgery: A randomised controlled study. Eur J Anaesthesiol. 2015 Aug;32(8):555-62. doi: 10.1097/EJA.0000000000000250.
Related trials for Valvular Heart Disease
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
RecruitingObservational study
Evaluation of Valvular Heart Disease Using Cardiac CT
Valvular Heart Disease
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Glucose-Insulin-Potassium)GIK group and normal saline group in people with Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 11 Oct 2013. 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 South Korea. 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?
perioperative blood lactate level (time frame: change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1)). 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 NCT01825720, 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 11 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.