Intraoperative Insulin Administration at Cardiac Surgery for Diabetic Patients
Status:
Completed
Trial end date:
2020-01-30
Target enrollment:
Participant gender:
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.