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Tight Glycaemic Control During Cardiac Surgery

NCT01225159 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-12-18

Study results available
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Summary

To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Conditions

  • Nosocomial Infection
  • External Causes of Morbidity and Mortality
  • Hypoglycemia

Interventions

DRUG

TGC

TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.

DRUG

Conventional glycaemic control

Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.

Sponsors & Collaborators

  • Prince of Songkla University

    lead OTHER

Principal Investigators

  • Panthila Rujirojindakul, M.D. · Faculty of Medicine, Prince of Songkla University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225159 on ClinicalTrials.gov