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

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ClinicalTrials.gov Identifier: NCT01825720
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):
Yonsei University

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2013
Primary Completion Date : May 2013
Study Completion Date : May 2013

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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825720

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01825720     History of Changes
Other Study ID Numbers: 4-2012-0347
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013

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

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