Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery

This study has been terminated.
(The recruitment rate slowed considerably)
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00328094
First received: May 18, 2006
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.

The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.


Condition Intervention
Peripheral Vascular Disease
Abdominal Aortic Aneurysm
Drug: continuous intravenous insulin infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Composite (Myocardial Infarction and CHF) [ Time Frame: hospital length of stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Wound Infections [ Time Frame: postoperative ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: March 2006
Study Completion Date: May 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CII, Continuous Insulin Infusion
Continuous intravenous insulin infusion to control glucose to <150 mg/dL in patients undergoing open peripheral vascular bypass surgery
Drug: continuous intravenous insulin infusion
Tight glucose control versus standard of care
Other Names:
  • CII-continuous insulin infusion
  • II-Intermittent insulin boluses
Active Comparator: IIB, Intermittent insulin boluses
Intermittent intravenous insulin insulin boluses to a blood glucose target of <150mg/dL in patients undergoing peripheral vascular bypass surgery
Drug: continuous intravenous insulin infusion
Tight glucose control versus standard of care
Other Names:
  • CII-continuous insulin infusion
  • II-Intermittent insulin boluses

Detailed Description:

This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit and in the postoperative vascular intensive care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity and mortality during the hospital admission and up to 30 days from surgery.

After obtaining informed consent, the study subjects will be randomized to tight versus standard blood glucose control regimens. These regimens will be started in the operating room and continued for the first 48 hours or until their discharge, whichever is earlier. All the patients will be inpatients. Day surgery patients will be excluded.

The anesthesiologist providing patient care will be given either the tight glucose control protocol or the standard sliding scale insulin protocol. In the tight control regimen, target blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level >150 mg/dL or 1 BG level >200 mg/dL, then the insulin infusion will be initiated in the tight control group. The insulin infusion rate adjustments will be made based on the blood sugar results. In post anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be nurse driven. The adjustments will be made based on the current blood sugar levels as well as the insulin infusion rates. They are adjusted in such a way to account for the rate of change of blood sugars and the presence of steroid therapy in the patients. The frequency of blood glucose testing in this group will be every 1-hour until stable (when frequent changes in insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3 consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar checks will be done every hour and the cycle followed thereafter.

In the standard sliding scale insulin group, blood sugars will be treated with insulin boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every 4 hours.

These regimens will be initiated after 2 weeks of in-service training for anesthesiologists, post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study investigators will provide this training. Insulin infusion in the tight control regimen will be started through pump piggyback to maintenance intravenous infusion as follows. Insulin infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus insulin administration, and infusion initiation and rate adjustments as specified by the protocol. Blood glucose levels will be tested by finger stick method or arterial line drop sample.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal aortic surgery
  • Supra and infrainguinal peripheral vascular bypass surgery
  • Below knee amputations
  • Above knee amputations
  • Diabetics and nondiabetics
  • American Society of Anesthesiologists (ASA) I-III

Exclusion Criteria:

  • Brittle diabetics
  • ASA 1V,V
  • Second surgery in same 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: NCT00328094

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Balachundhar Subramaniam Beth Israel Deaconess Medical Center, Boston, MA
  More Information

Publications:
Responsible Party: Balachundhar Subramaniam, Staff Anesthesiologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00328094     History of Changes
Other Study ID Numbers: 2005P-000299
Study First Received: May 18, 2006
Results First Received: February 28, 2013
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Tight
Glycemic
control
outcomes
peripheral vascular disease
infection
cardiovascular
morbidity
mortality

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Aortic Aneurysm, Abdominal
Cardiovascular Diseases
Aortic Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014