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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01825720
First received: March 26, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 Intervention
Valvular Heart Disease
Drug: (Glucose-Insulin-Potassium)GIK group
Drug: normal saline group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group


Enrollment: 106
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01825720

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01825720     History of Changes
Other Study ID Numbers: 4-2012-0347
Study First Received: March 26, 2013
Last Updated: October 10, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
GIK, valvular heart surgery, lactate

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014