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

Not Applicable

Completed

• Conditions: Valvular Heart Disease
• Interventions: Drug: (Glucose-Insulin-Potassium)GIK group; Drug: normal saline group

• Registration Number: NCT01825720
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Glucose-Insulin-Potassium)GIK group	(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	normal saline group	same rate of normal saline

Primary Outcome Measures

Name	Time	Method
perioperative blood lactate level	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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute; 🇰🇷 Seoul, Korea, Republic of