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

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.

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Key information

Conditions

Blood Glucose

Age range

43 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan royal medical service

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Insulin Infusion

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Audai A. Hayajneh

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jun 30, 2020
Registry last updated: Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed