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Completed

NCT Number: NCT00282698

Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

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.

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Key information

Conditions

Cardiac Surgical Procedures Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects accepted for this study must be:

  • >=18 years of age
  • Undergoing an elective cardiac surgical procedure

Exclusion criteria

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

  • Undergoing surgery not utilizing cardiopulmonary bypass
  • Unable to grant informed consent or comply with study procedure
  • Undergoing emergency open heart-surgery
  • Are allergic to any of the excipients in insulin

Treatment and study plan

Insulin infusion with a goal

Drug

Primary outcomes

  1. Mortality

  2. Sternal wound infections

  3. Stroke

  4. Cardiac arrhythmias

  5. Renal failure

Secondary outcomes

  1. Lenght of intensive care unit stay

  2. Length of hospital stay

  3. Safety of study insulin infusion

  4. Efficacy of study insulin infusion

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2006
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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