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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:
ClinicalTrials.gov Identifier:
NCT00487162
First Posted: June 15, 2007
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
  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: intensive glycemic control Drug: conventional glycemic control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • Wound Infection [ Time Frame: 7-10 days post op ]

Secondary Outcome Measures:
  • Hemodynamic Instability [ Time Frame: 0-48 hours post op ]

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: intensive glycemic control
In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. If the glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued.
Procedure: intensive 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
In this group if the subject's blood glucose level should exceed 200 mg/dL the subject will be treated with a continuous insulin infusion to maintain blood glucose levels between 180-200mg/dL
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00487162     History of Changes
Other Study ID Numbers: 0120070093
First Submitted: June 13, 2007
First Posted: June 15, 2007
Results First Submitted: December 3, 2010
Results First Posted: April 3, 2014
Last Update Posted: November 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
glycemic control, diabetes, obesity, comorbidities

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