NCT01825720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

March 26, 2013

Last Update Submit

October 10, 2013

Conditions

Valvular Heart Disease

Keywords

GIK, valvular heart surgery, lactate

Outcome Measures

Primary Outcomes (1)

  • perioperative blood lactate level

    Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group

    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)

Study Arms (2)

(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

Drug: (Glucose-Insulin-Potassium)GIK group

normal saline group

ACTIVE COMPARATOR

same rate of normal saline

Drug: normal saline group

Interventions

(Glucose-Insulin-Potassium)GIK groupDRUG

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

(Glucose-Insulin-Potassium)GIK group
normal saline groupDRUG

same rate of normal saline

normal saline group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:
  • congestive heart failure
  • infective endocarditis
  • redo valvular surgery
  • surgery combined with coronary bypass graft
  • multiple valvular surgery
  • 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%

You may not qualify if:

  • emergency surgery
  • hemodynamic instability before surgery (mean arterial pressure \< 60 mmHg, heart rate \>100 /min
  • need for pharmacological or mechanical assist for hemodynamic stability before surgery
  • baseline blood lactate level more than 2 mmol/l
  • on steroid or NSAID
  • hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Roh GU, Shim JK, Song JW, Kang HM, Kwak YL. Effect of glucose-insulin-potassium on hyperlactataemia in patients undergoing valvular heart surgery: A randomised controlled study. Eur J Anaesthesiol. 2015 Aug;32(8):555-62. doi: 10.1097/EJA.0000000000000250.

    PMID: 25760680DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 8, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

KR(1)