Intraoperative Insulin Administration (Infusion Regimen vs. Bolus Regimen) at Cardiac Surgery for Type II Diabetic Patients; A Randomised Control Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- The Hashemite University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Intraoperative level of glucose
Study Overview
Brief 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.
Detailed Description
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 and study registration Ethical approval for the study was obtained from the Office for Research Ethics Committees at Hashemite University - Prince Hamza hospital with reference number 2/1/2019/2020.
Methods and Materials 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. In addition to signing the consent form, patients were recruited when they met the following criteria: >40 years old, patients who need the usual insulin according to insulin dosing guidelines, patients with pre-operation glucose level > 200 mg/dL and < 300 mg/dL.
The following patients were excluded: Insulin sensitive patents (Age >70 years, Glomerular Filtration Rate (GFR) <45 ml/min, No history of Diabetes, Insulin resistance patients (Body Mass Index > 35 kg/m2, total daily insulin dose >80 units, Steroids > 20 mg prednisone daily, patients who at high risk of complications and or (those whom their operation was differed to be supervised by a specialized team). Patients who were unable to give written informed consent, who had ≥4 emergency admissions during the six months prior to the index admission.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetic patients, type 2, who were admitted to hospital for cardiac surgery.
- •Patient above 40 years old,
- •Patients who need the usual insulin according to insulin dosing guidelines
- •Patients with pre-operation glucose level > 200 mg/dL and < 300 mg/dL.
Exclusion Criteria
- •Insulin sensitive patents (Age >70 years, Glomerular Filtration Rate (GFR) <45 ml/min, No history of Diabetes, Insulin resistance patients (Body Mass Index > 35 kg/m2, total daily insulin dose >80 units, Steroids > 20 mg prednisone daily, patients who at high risk of complications and or (those whom their operation was differed to be supervised by a specialized team).
- •Patients who were unable to give written informed consent.
- •Patients have ≥4 emergency admissions during the six months prior to the index admission.
Arms & Interventions
Insulin infusion regimen
Adult type II diabetic patients, who were admitted to hospital for cardiac surgery. These group received their dose of insulin; Insulin infusion regimen.
Fast-acting human insulin (Actrapid®) was used in this group.
Intervention: Fast-acting human insulin (Drug)
Insulin bolus regimen
Adult type II diabetic patients, who were admitted to hospital for cardiac surgery. These group received their dose of insulin; Insulin bolus regimen.
Fast-acting human insulin (Actrapid®) was used in this group.
Intervention: Fast-acting human insulin (Drug)
Outcomes
Primary Outcomes
Intraoperative level of glucose
Time Frame: Change from baseline glucose level (preoperative) at six hours intraoperative
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 Outcomes
- Insulin quantities(Change from baseline glucose level (preoperative) at six hours intraoperative)
Investigators
Mohanad Mousa Taha Odeh
Director of Pharmacy Management & Pharmaceutical Care Innovation Centrer
The Hashemite University