Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery

June 25, 2020 updated by: Audai A. Hayajneh

Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.

Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.

Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group (n=72) or a conventional glycemic control group (n=72). Patients who received the tight glycemic control protocol had significantly more consistent and lower mean intraoperative BG levels than those who received the conventional glycemic control protocol. The tight glycemic control protocol resulted in significantly lower BG levels and fewer variations across each time-point and more consistent and stable BG levels than the conventional glycemic control protocol.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Jordan royal medical service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult Jordanian patients
  • diagnosed with DM
  • who had been scheduled to CABG surgery

Exclusion Criteria:

  • Participants who were immunosuppressed were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interventional
Drug: Continuous insulin infusion
This study aims to explore the hypothesis that diabetic patients undergoing coronary artery bypass graft (CABG) surgery receiving intravenous continuous insulin infusion (CII) for tight glycemic control (110-149 mg/dl) protocol during the intraoperative period would have improved intraoperative glycemic stability, efficacy and consistency compared to patients receiving conventional glycemic control (150-180 mg/dl) protocol during the intraoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative glycemic instability
Time Frame: every half hour for eight hours
Intraoperative glycemic instability is defined as three consecutive readings of intraoperative blood glucose (BG) levels outside the pre-set targeted ranges of the protocols, whether higher or lower than the limits
every half hour for eight hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Audai A. Hayajneh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

November 30, 2018

Study Completion (ACTUAL)

November 30, 2018

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (ACTUAL)

June 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUST20180441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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