Cerebral-tissue Oxygen Balance Affected by Diabetes Mellitus

NCT03668301 | Completed

• 1 other identifier: WHO2788
• Study Type: observational
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

The brain has high oxygen extraction, thus the regional cerebral tissue oxygen saturation (rSO2) is lower than the central venous oxygen saturation (ScvO2). The investigators hypothesized that diabetes widens the physiological saturation gap between ScvO2 and rSO2 (gSO2), and the width of this gap may vary during various phases of cardiac surgery. The investigators involve cardiac surgery patients with and without type 2 diabetes mellitus (T2DM) undergoing either off-pump coronary artery bypass (OPCAB) or other cardiac surgery necessitating cardiopulmonary bypass (CPB). rSO2 is measured by near-infrared spectroscopy (NIRS) and ScvO2 is determined simultaneously from central venous blood. rSO2 is registered before and after anesthesia induction and at different stages of the surgery.

Conditions

Diabetes Mellitus (D003920); Cardiac Surgical Procedures (D006348); Near-Infrared (D019265)

Outcome Measures

Primary Outcomes (2)

• Cerebral tissue oxygen saturation

  The spatially resolved continuous-wave NIRS technique is applied to estimate cerebral tissue oxygen saturation. This monitor uses two different wavelengths (730 and 810 nm) and has two detectors positioned 3 and 4 cm from the light source. Computing the differences between the intensity of the emitted and the reflected light 13 with two receivers 14 allows the measurement of the oxygen saturation of the cerebral cortex. In this study, two adult sensors are applied on the left and right sides of the patient's forehead symmetrically, and the cerebral-tissue oxygen saturation is monitored continuously during the surgical procedures and the data are registered in each protocol stage. The mean value of the rSO2 measured by the sensors is calculated for each protocol stage and used for further analyses.

  Intraoperative interval during cardiac surgery starting from anesthsia induction until end of the surgery.

• Central venous oxygen saturation

  The central venous oxygen saturation is measured from central venous blood samples (Radiometer ABL 505, Copenhagen, Denmark). The proper positioning of the central venous catheter is verified by the surgeon via manually palpating the catheter tip.

  Intraoperative interval during cardiac surgery starting from anesthsia induction until end of the surgery.

Study Arms (4)

Group CPB-T2DM

Patients with diabetes mellitus undergoing cardiac surgery with cardiopulmonary bypass

Group OPCAB-T2DM

Patients with diabetes mellitus undergoing cardiac surgery without cardiopulmonary bypass

Group CPB-C

Control patients undergoing cardiac surgery with cardiopulmonary bypass

Group OPCAB-C

Control patients undergoing cardiac surgery without cardiopulmonary bypass

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients enrolled at the Second Department of Internal Medicine and Cardiology Center Cardiac Surgical Unit, University of Szeged

You may qualify if:

• Patients undergoing cardiac surgery with or without diabetes mellitus,
• Age between 18-80 years

You may not qualify if:

• Patients older than 80 years of age,
• Poor ejection fraction (\<40%),
• Unilateral internal carotid stenosis (\>75%),
• Medical history of smoking,
• Medical history of chronic obstructive pulmonary disease
• Medical history of stroke

Sponsors & Collaborators

• Szeged University: lead
• Hungarian Basic Research Council: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior lecturer

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 12, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 24, 2018

Record last verified: 2018-09