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Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

This study is currently recruiting participants.
Verified October 2012 by Outcomes Research Consortium
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00524472
First received: August 31, 2007
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Surgery
 Other: Hyperinsulinemic-normoglycemic clamp
Other: insulin at the standard of care levels

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • To assess the effect of hyperinsulinemic-normoglycemic clamp therapy versus standard therapy on the proportion of patients having one or more outcome events [ Time Frame: 15-30 days post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health-related quality of life [ Time Frame: 15 and 30 days post operative ] [ Designated as safety issue: No ]
    To compare the randomized groups on continuous outcomes including health-related quality of life (at 15 and 30) days

  • post operative atrial fibrillation [ Time Frame: 15-30 days post operative ] [ Designated as safety issue: No ]
    Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery

  • post operative delirium [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    New postoperative delirium as determined by a Delirium Battery consisting of the Richmond Agitation and Sedation Scale (RASS), Confusion Assessment Method for the ICU (CAM-ICU), Mini Mental State Examination (MMSE - leaving out the drawing), Memorial Delirium Assessment Scaler, Modified Delirium Symptom Interview, and abbreviated Digit Span. Patients will be assessed twice a day for a maximum of five days postoperatively.

  • wound healing [ Time Frame: 15-30 days post operative ] [ Designated as safety issue: No ]
    Measured by wound collagen disposition, hydroxyproline content, and other mediators of wound healing (e.g. collagenase, cell matrix components, and matricellular proteins such as thrombospondin).

  • Duration of hospitalization [ Time Frame: starting post operative day one ] [ Designated as safety issue: No ]
    Days from day of surgery to hospital discharge.

  • Duration of Intensive Care stay [ Time Frame: starting post operative day one ] [ Designated as safety issue: No ]
    Days from day of surgery to discharge from intensive care unit.

  • all-cause mortality [ Time Frame: one year post operative ] [ Designated as safety issue: No ]
    All-cause mortality identified during one-year follow-up.


Estimated Enrollment: 418
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperinsulinemic-normoglycemic clamp
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
 Other: Hyperinsulinemic-normoglycemic clamp
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
Other Names:
  • clamp
  • Hyperinsulinemic
Insulin at the standard of care levels
Group B will be administered insulin at the standard of care levels established by the participating institution.
 Other: insulin at the standard of care levels
Subjects will be administered insulin at the standard of care levels established by the participating institution.
Other Name: insulin

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-90 years old
  • Scheduled for cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria:

  • Off-pump surgical procedures
  • Anticipated deep hypothermic circulatory arrest
  • In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
  • Any contraindications to the proposed interventions
  • Active infection, including patients with endocarditis or infected pacemaker leads.
  • Any infection requiring long- term antibiotics ( > 14 days)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524472

Contacts
Contact: Andra I Duncan, M.D. 216/445-2372 duncana@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Andra I Duncan, M.D. The Cleveland Clinic
Study Director: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Thomas Schricker, MD Royal Victoria Hospital, Montreal, Canada
Principal Investigator: George Carvalho, MD Royal Victoria Hospital, Montreal, Canada
  More Information

No publications provided

Responsible Party: Andra Duncan, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00524472     History of Changes
Other Study ID Numbers: 07-470
Study First Received: August 31, 2007
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Hyperinsulinemic glucose control
cardiac surgery
Outcome

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013