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Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery

NCT00394303 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2009-04-01

No results posted yet for this study

Summary

Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units.

We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.

Conditions

  • Coronary Artery Bypass

Interventions

DRUG

Intraoperative continuous insulin infusion

Nomogram specified in appendix

OTHER

Control

Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels \<200 mg.dl, reflecting current practice.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Mical Paul, MD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Completion
2009-08-31

Countries

  • Israel

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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 NCT00394303 on ClinicalTrials.gov