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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01825720

Collaborator

(none)

106

Enrollment

Location

Arms

Duration (Months)

52.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Heart Disease	Drug: (Glucose-Insulin-Potassium)GIK group Drug: normal saline group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (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	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
Active Comparator: normal saline group same rate of normal saline	Drug: normal saline group same rate of normal saline

Arm

Intervention/Treatment

Experimental: (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

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

Active Comparator: normal saline group

same rate of normal saline

Drug: normal saline group

same rate of normal saline

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01825720

Other Study ID Numbers:

4-2012-0347

First Posted:

Apr 8, 2013

Last Update Posted:

Oct 11, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Yonsei University

GIK, valvular heart surgery, lactate

Additional relevant MeSH terms:

Heart Diseases

Heart Valve Diseases

Insulin

Study Results

No Results Posted as of Oct 11, 2013