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

Yonsei University

Status: Completed

Conditions: Valvular Heart Disease

Treatments: Drug: (Glucose-Insulin-Potassium)GIK group; Drug: normal saline group

Study type: Interventional

Funder types: Other

Identifiers

NCT01825720

4-2012-0347

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

(Glucose-Insulin-Potassium)GIK group

Experimental group

Description:

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

Treatment:

Drug: (Glucose-Insulin-Potassium)GIK group

normal saline group

Active Comparator group

Description:

same rate of normal saline

Treatment:

Drug: normal saline group