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

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.

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Key information

Conditions

Valvular Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%

Exclusion criteria

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

Treatment and study plan

(Glucose-Insulin-Potassium)GIK group

Drug

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

Drug

same rate of normal saline

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Apr 8, 2013
Registry last updated: Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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