The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

This study has been terminated.
(potential harm of insulin infusion outweights the benefit.)
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00487162
First received: June 13, 2007
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

Surgery induces a stress effect on the body partially through a catabolic energy state. In turn, glucose levels may rise to levels which have been associated with major morbidity (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that intensive insulin therapy for tight control of blood glucose levels in certain surgical and critical care patient populations may improve mortality and selected morbidity outcomes when compared to those patients receiving conventional insulin therapy and blood glucose management. More specifically, poor intra-operative blood glucose control is associated with worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose control in surgical patients while in the ICU may reduce morbidity and mortality. Such outcome improvements would clearly provide benefits to patients, providers and payers. To date, there is scant research examining whether intensive insulin therapy for tight control of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery population. The purpose of this study is to determine whether intensive insulin therapy for tight control of blood glucose in the perioperative period in non cardiac major surgery patients is associated with altered morbidity and mortality rates.


Condition Intervention
Hyperglycemia
Procedure: strict glycemic control
Drug: conventional glycemic control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Wound Infection [ Time Frame: 7-10 days post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemodynamic Instability [ Time Frame: 0-48 hours post op ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strict glycemic control Procedure: strict glycemic control
intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
Other Name: Novo Regular Insulin
Active Comparator: conventional glycemic control Drug: conventional glycemic control
Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for non emergent surgery under either general or regional anesthesia deemed to have moderate to high physiologic stress
  • Male and female subjects over the age of 18 with or without a diagnosis of diabetes mellitus
  • Patients must be able to provide informed consent

Exclusion Criteria:

  • Cognitively impaired
  • Non-English or Spanish speaking with no relative present who is fluent in reading and comprehending English or Spanish.
  • Female patients of child bearing age who have a positive pregnancy test on admission.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487162

Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07107
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: J Jeffery Freda, MD, MBA Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00487162     History of Changes
Other Study ID Numbers: 0120070093
Study First Received: June 13, 2007
Results First Received: December 3, 2010
Last Updated: February 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
glycemic control, diabetes, obesity, comorbidities

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 July 24, 2014