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Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00524472
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Other: Hyperinsulinemic-normoglycemic clamp Other: insulin at the standard of care levels Not Applicable

Detailed Description:

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 outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.

Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
Actual Study Start Date : July 2007
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Any Major Morbidity/30-day Mortality [ Time Frame: within 30 days post surgery ]

    a composite (any versus none) of the following major postoperative complications occurring:

    1. all-cause postoperative mortality
    2. failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation
    3. serious postoperative infection
    4. acute postoperative kidney injury requiring renal replacement therapy;
    5. new postoperative focal or global neurologic deficit.


Secondary Outcome Measures :
  1. Post Operative Atrial Fibrillation [ Time Frame: 15 - 30 days post operative ]
    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

  2. Duration of Hospitalization [ Time Frame: starting post operative day one to discharge from hospital, on an average of 8 days ]
    Days from date of surgery to hospital discharge

  3. Duration of Intensive Care Stay [ Time Frame: ICU stay hours during hospital stay after surgery, on average of 25 hours ]
    Hours from date of surgery to discharge from intensive care unit

  4. All-cause Mortality [ Time Frame: one year post operative ]
    All-cause mortality identified during one-year follow-up.

  5. a Composite of Minor Postoperative Complications [ Time Frame: within 30 days after surgery ]
    a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
  • kidney disease requiring renal replacement therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524472


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
The Cleveland Clinic
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00524472     History of Changes
Other Study ID Numbers: 07-470
First Posted: September 3, 2007    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Hyperinsulinemic glucose control
cardiac surgery
Outcome

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs