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

Primary Purpose

Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
(Glucose-Insulin-Potassium)GIK group
normal saline group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Valvular Heart Disease focused on measuring GIK, valvular heart surgery, lactate

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(Glucose-Insulin-Potassium)GIK group

normal saline group

Arm 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

same rate of normal saline

Outcomes

Primary Outcome Measures

perioperative blood lactate level
Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group

Secondary Outcome Measures

Full Information

First Posted
March 26, 2013
Last Updated
October 10, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01825720
Brief Title
Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
GIK, valvular heart surgery, lactate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Glucose-Insulin-Potassium)GIK group
Arm Type
Experimental
Arm 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
Arm Title
normal saline group
Arm Type
Active Comparator
Arm Description
same rate of normal saline
Intervention Type
Drug
Intervention Name(s)
(Glucose-Insulin-Potassium)GIK group
Intervention 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
Intervention Type
Drug
Intervention Name(s)
normal saline group
Intervention Description
same rate of normal saline
Primary Outcome Measure Information:
Title
perioperative blood lactate level
Description
Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25760680
Citation
Roh GU, Shim JK, Song JW, Kang HM, Kwak YL. Effect of glucose-insulin-potassium on hyperlactataemia in patients undergoing valvular heart surgery: A randomised controlled study. Eur J Anaesthesiol. 2015 Aug;32(8):555-62. doi: 10.1097/EJA.0000000000000250.
Results Reference
derived

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

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