---
title: Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
nct_id: NCT01825720
overall_status: COMPLETED
phase: NA
sponsor: Yonsei University
study_type: INTERVENTIONAL
primary_condition: Valvular Heart Disease
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01825720.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01825720"
ct_last_update_post_date: 2013-10-11
last_seen_at: "2026-05-12T06:10:20.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery

**NCT ID:** [NCT01825720](https://clinicaltrials.gov/study/NCT01825720)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 106
- **Lead Sponsor:** Yonsei University
- **Conditions:** Valvular Heart Disease
- **Start Date:** 2013-03
- **Completion Date:** 2013-05
- **CT.gov Last Update:** 2013-10-11

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Arms

- **(Glucose-Insulin-Potassium)GIK group** (EXPERIMENTAL) — 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
- **normal saline group** (ACTIVE_COMPARATOR) — same rate of normal saline

## Interventions

- **(Glucose-Insulin-Potassium)GIK group** (DRUG) — 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
- **normal saline group** (DRUG) — same rate of normal saline

## Primary Outcomes

- **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

## Locations (1)

- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Seoul, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of anesthesiology and pain medicine, anesthesia and pain research institute|seoul|seoul|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01825720.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01825720*  
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