Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01825720
Enrollment
106
Registered
2013-04-08
Start date
2013-03-31
Completion date
2013-05-31
Last updated
2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

Keywords

GIK, valvular heart surgery, lactate

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.

Interventions

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

same rate of normal saline

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
perioperative blood lactate levelchange 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026