Skip to main content
OpenTrials
Completed

NCT Number: NCT00460499

Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glycemic Control Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetic CABG patients

Exclusion criteria

  • Renal and hepatic failure

Treatment and study plan

A IV Insulin drip

Drug

These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.

B Low Dose GIK

Drug

These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl

C High Dose GIK

Drug

This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl

Primary outcomes

  1. glycemic control, postoperative morbidity, inflammatory markers

    Time frame: 24 hours following surgery

  2. glycemic control

    Time frame: 24 hours following surgery

Secondary outcomes

  1. free fatty acid levels

    Time frame: 24 hours following surgery

Sponsors and collaborators

Lead sponsor

American Heart Association

Other

Registry information

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2007
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.