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Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT00282698
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : May 23, 2011
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Surgical Procedures Hyperglycemia Drug: Insulin infusion with a goal Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Mortality
  2. Sternal wound infections
  3. Stroke
  4. Cardiac arrhythmias
  5. Renal failure

Secondary Outcome Measures :
  1. Lenght of intensive care unit stay
  2. Length of hospital stay
  3. Safety of study insulin infusion
  4. Efficacy of study insulin infusion


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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): 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

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
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011

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