Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery

Valvular Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825720
• Other study ID #: 4-2012-0347
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: October 10, 2013
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: October 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:

1. congestive heart failure

2. infective endocarditis

3. redo valvular surgery

4. surgery combined with coronary bypass graft

5. multiple valvular surgery

6. 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%

Exclusion Criteria:

1. emergency surgery

2. hemodynamic instability before surgery (mean arterial pressure < 60 mmHg, heart rate >100 /min

3. need for pharmacological or mechanical assist for hemodynamic stability before surgery

4. baseline blood lactate level more than 2 mmol/l

5. on steroid or NSAID

6. hepatic dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Drug:
• (Glucose-Insulin-Potassium)GIK group
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 group
same rate of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative blood lactate level	Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group	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)	No