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

March 26, 2013
October 10, 2013
March 2013
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01825720 on ClinicalTrials.gov Archive Site
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Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
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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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Valvular Heart Disease
  • 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
  • Drug: normal saline group
    same rate of normal saline
  • 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
    Intervention: Drug: (Glucose-Insulin-Potassium)GIK group
  • Active Comparator: normal saline group
    same rate of normal saline
    Intervention: Drug: normal saline group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01825720
4-2012-0347
No
Yonsei University
Yonsei University
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Yonsei University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP