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

NCT00487162 | Terminated Results

• 1 other identifier: 0120070093
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Keywords

glycemic control, diabetes, obesity, comorbidities

Outcome Measures

Primary Outcomes (1)

• Wound Infection

  7-10 days post op

Secondary Outcomes (1)

• Hemodynamic Instability

  0-48 hours post op

Study Arms (2)

intensive glycemic control

EXPERIMENTAL

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

conventional glycemic control

ACTIVE COMPARATOR

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

Interventions

intensive glycemic control PROCEDURE

intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl

Also known as: Novo Regular Insulin

intensive glycemic control

conventional glycemic control DRUG

Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl

conventional glycemic control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07107, United States

Location

Related Publications (3)

• van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

  PMID: 11794168 BACKGROUND

• Furnary AP, Gao G, Grunkemeier GL, Wu Y, Zerr KJ, Bookin SO, Floten HS, Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003 May;125(5):1007-21. doi: 10.1067/mtc.2003.181.

  PMID: 12771873 BACKGROUND

• Ouattara A, Lecomte P, Le Manach Y, Landi M, Jacqueminet S, Platonov I, Bonnet N, Riou B, Coriat P. Poor intraoperative blood glucose control is associated with a worsened hospital outcome after cardiac surgery in diabetic patients. Anesthesiology. 2005 Oct;103(4):687-94. doi: 10.1097/00000542-200510000-00006.

  PMID: 16192760 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated. No final conclusion drawn. A sentinel article was published in Feb 2009 issue of Anesthesiology which questioned the safety of intense insulin therapy/strict glycemic control.

Results Point of Contact

• Title: J. Jeffrey Freda, MD, MBA
• Organization: UMDNJ-NJMS

jjfreda@umdnj.edu

973 972-5007

Study Officials

• J Jeffery Freda, MD, MBA

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 15, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 8, 2016
• Results First Posted: April 3, 2014

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)