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Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

NCT00524472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1439

Last updated 2018-10-26

Study results available
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Summary

Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.

Conditions

  • Cardiac Surgery

Interventions

OTHER

Hyperinsulinemic-normoglycemic clamp

Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.

OTHER

insulin at the standard of care levels

Subjects will be administered insulin at the standard of care levels established by the participating institution.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Andra I Duncan, M.D. · The Cleveland Clinic

  • Daniel I Sessler, M.D. · The Cleveland Clinic

  • Thomas Schricker, MD · Royal Victoria Hospital, Montreal, Canada

  • George Carvalho, MD · Royal Victoria Hospital, Montreal, Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Canada

Study Locations

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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 NCT00524472 on ClinicalTrials.gov