Intraoperative Insulin Administration at Cardiac Surgery for Diabetic Patients

NCT04824586 | Completed Phase 4

• 1 other identifier: Intraoperative Insulin
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Cardiac Event

Keywords

Type II diabetes mellitus; Cardiac surgery; Insulin; Insulin infusion regimen; Insulin bolus regimen

Outcome Measures

Primary Outcomes (1)

• Intraoperative level of glucose

  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.

  Change from baseline glucose level (preoperative) at six hours intraoperative

Secondary Outcomes (1)

• Insulin quantities

  Change from baseline glucose level (preoperative) at six hours intraoperative

Study Arms (2)

Insulin infusion regimen

EXPERIMENTAL

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.

Drug: Fast-acting human insulin

Insulin bolus regimen

EXPERIMENTAL

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.

Drug: Fast-acting human insulin

Interventions

Fast-acting human insulin DRUG

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.

Also known as: Actrapid®

Insulin bolus regimen; Insulin infusion regimen

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hashemite University: lead

Study Sites (1)

Prince Hamza Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohanad M Odeh, PhD

  The Hashemite University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pharmacy Management & Pharmaceutical Care Innovation Centrer

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

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: April 1, 2021
• Study Start: June 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)