Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery

Cardiovascular Diseases Clinical Trial

Official title:

Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836329
• Other study ID #: 615
• Secondary ID: R01 HL089115-01
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2009
• Last updated: July 11, 2016
• Start date: December 2008
• Est. completion date: May 2014

Study information

• Verified date: July 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Preliminary studies have shown that people with diabetes who undergo heart surgery may have a higher risk of developing cognitive functioning problems, including memory problems, than people without diabetes who undergo heart surgery. Among people with diabetes, however, those who control their blood sugar levels in a more intensive way during and after heart surgery may have better neurological outcomes than those who use a standard method of controlling their blood sugar levels. This study will compare the effectiveness of using a traditional method of blood sugar control versus a more intensive method of blood sugar control during and after heart surgery for improving neurological outcomes in people with diabetes.

Description:

People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There may be a connection between disturbances in glucose metabolism, endothelial dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who receive more intensive blood glucose management during and after heart surgery may have better neurological outcomes than people who control their blood glucose levels in a standard way. The purpose of this study is to evaluate the effectiveness of using a traditional method of controlling blood glucose levels versus a tailored, more intensive method of glucose control on neurological outcomes in people with diabetes who are undergoing heart surgery. Researchers will also examine genetic factors that may be associated with insulin resistance and inflammation.

This study will enroll people undergoing heart surgery. On the day before surgery, participants will undergo a blood collection and neuropsychological testing. They will then be randomly assigned to either a traditional method of blood glucose control or an intensive, tailored method of blood glucose control. Participants following the traditional method of blood glucose control may receive insulin several times a day, based on the results of glucose monitoring. Participants following the intensive, tailored method of blood glucose control will undergo hourly measurements of their glucose levels and receive insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery, all participants will undergo an ultrasound of their neck to monitor blood vessel activity. Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours after surgery, and upon hospital discharge or 5 days after surgery.

One week after surgery or just before leaving the hospital, participants will undergo a magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving the hospital, participants will take part in a diabetes education session and nutrition counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat neuropsychological testing. Once a month for 6 months, participants who received the intensive, tailored method of blood glucose control will attend study visits at which time study researchers will monitor their diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission

• Scheduled to undergo coronary artery bypass graft (CABG) surgery

• Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both

• Scheduled to undergo valve replacement with CABG

Exclusion Criteria:

• Undergoing emergent (i.e., urgent) procedures

• Alzheimer's disease or similar dementias

• Severe claustrophobia

• Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL

• Cannot be expected to complete neuropsychological testing

• Recent extensive, life threatening acute myocardial infarction (AMI)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus

Intervention

Behavioral:
• Intensive Glucose Management
Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU). Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL. Prior to hospital discharge, participants will receive an in-depth diabetes education session. After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
• Traditional Glucose Management:
Participants will receive traditional management of blood glucose levels while in the hospital. They may receive insulin several times a day, based on the results of glucose monitoring.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)		Measured 1 week after surgery	No
Primary	Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)		Measured 6 months after surgery	No
Secondary	Number of lesions, as measured by MRI		Measured 1 week after surgery	No
Secondary	Size of lesions, as measured by MRI		Measured 1 week after surgery	No
Secondary	Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)		Measured 6 months after surgery	No
Secondary	Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)		Measured 6 months after surgery	No