Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00282698
First received: January 26, 2006
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.


Condition Intervention Phase
Cardiac Surgical Procedures
Hyperglycemia
Drug: Insulin infusion with a goal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mortality
  • Sternal wound infections
  • Stroke
  • Cardiac arrhythmias
  • Renal failure

Secondary Outcome Measures:
  • Lenght of intensive care unit stay
  • Length of hospital stay
  • Safety of study insulin infusion
  • Efficacy of study insulin infusion

Estimated Enrollment: 400
Study Start Date: July 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Rigorous intraoperative glycemic control may be of paramount importance in affecting outcomes after cardiac surgery. There is evidence that strict control of glucose levels postoperatively results in improved outcomes in patients undergoing cardiac surgery. There is currently no consensus on optimal management of hyperglycemia intraoperatively. The aim of this prospective randomized controlled clinical trial is to determine whether normalization of intraoperative glucose levels with insulin improves outcomes. The comparison group will be treated with current standard practice to control hyperglycemia during surgery. The primary outcome is a composite of mortality, sternal wound infections, prolonged pulmonary ventilation, cardiac arrhythmias (new-onset atrial fibrillation, heart block requiring permanent pacemaker, cardiac arrest), stroke and acute or worsening renal failure within 30 days after surgery. Secondary outcome measures are length of intensive care unit and hospital stay as well as safety and efficacy of the study insulin infusion protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

All subjects accepted for this study must be:

  1. >=18 years of age
  2. Undergoing an elective cardiac surgical procedure

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

  1. Undergoing surgery not utilizing cardiopulmonary bypass
  2. Unable to grant informed consent or comply with study procedure
  3. Undergoing emergency open heart-surgery

3. Are allergic to any of the excipients in insulin

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282698

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Novo Nordisk A/S
Investigators
Principal Investigator: Gunjan Y. Gandhi, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00282698     History of Changes
Other Study ID Numbers: 322-04
Study First Received: January 26, 2006
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014