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Intraoperative Insulin Administration at Cardiac Surgery for Diabetic Patients

NCT04824586 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-04-01

No results posted yet for this study

Summary

The primary objective of the study was to explore which insulin-based regimen is better, infusion or bolus regimen, for intraoperative management of glucose level for the diabetic patient at cardiac surgery. Secondary objectives include: comparing the relative amounts of insulin needed during the operation and subsequent cost impact and comparing potassium levels between groups.

Ethical approval for the study was obtained from the Office for Research Ethics Committees at Hashemite University - Prince Hamza hospital.

This study was a parallel-group, randomized, controlled trial with 1:1 allocation ratio.

Participants: Adult diabetic patients, type 2, who were admitted to hospital for cardiac surgery.

The intervention: Both patients in the infusion or bolus group received their dose of insulin, fast-acting human insulin (Actrapid®) was used.

Setting: Patients were recruited at Prince Hamza hospital, Amman, Jordan. A tertiary care center specialized unit in cardiac surgery for diabetic patients.

Outcomes monitoring: It was monitored six times as follows: preoperative induction measure, then glucose post heparin, and after that for 2 hours, glucose levels were monitored every 30 minutes. Insulin quantities were recorded as well to be used in secondary outcomes analysis.

Randomization, allocation, and blinding During patient enrolment, concealed allocation to either infusion group or bolus group was guaranteed through the use of a closed envelope system prepared by an independent investigator. Block randomization with random block sizes, ensured allocation balance, and avoided selection bias by preventing allocation prediction. Researchers and physicians were blind to the block size sequence and randomization. Envelopes were unopened until completion of patient registration. Hospital staff who monitor glucose and those who administered insulin were blinded to the primary and secondary outcomes' measure.

Conditions

Interventions

DRUG

Fast-acting human insulin

Both patients in the infusion or bolus group received their dose of insulin. The protocol of the insulin regimen and its related details were carried out according to the standard recommendations in a hospital where the trial done.

Sponsors & Collaborators

  • The Hashemite University

    lead OTHER

Principal Investigators

  • Mohanad M Odeh, PhD · The Hashemite University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Jordan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824586 on ClinicalTrials.gov