Automated vs Conventional Perioperative Glycemic Control in Diabetic Patients Undergoing Cardiopulmonary Bypass Surgery

NCT03314272 | Completed

• 1 other identifier: ANES.RK.03
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to evaluate a fully automated algorithm for the establishment of glycemic control in diabetic patients and to compare the results with routine management of hyperglycemia in patients undergoing cardiopulmonary bypass surgery.

Conditions

Diabetes; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (3)

• Percentage of patients who will have a serum glucose level between 140-180mg/dl during surgery.

  The reduction of this percentage to less than 10% with the fully automated algorithm as clinically significant

  Throughout the surgery period and postoperatively (admission to the CSU)

• Percentage of patients who had hyperglycemic events

  At least one hyperglycemic event over the surgery time

  Throughout the surgery periodThroughout the surgery period and postoperatively (admission to the CSU)

• Percentage of patients who had hypoglycemic events

  At least one hypoglycemic event over the surgery time

  Throughout the surgery periodThroughout the surgery period and postoperatively (admission to the CSU)

Study Arms (2)

Sliding scale protocol

NO INTERVENTION

Consists of giving insulin every 30 minutes based on the blood glucose readings as follows: * \<150 mg/dl: 0 units of insulin * 150-220 mg/dl: 2 units of insulin * 201-250 mg/dl: 4 units * 251-300 mg/dl: 6 units * 301-350 mg/dl: 8 units * 351-400 mg/dl: 10 units * \> 400 mg/dl: inform the MD on call

Space Glucose Control

EXPERIMENTAL

Automated protocol consisting of an insulin infusion pump named The Space Glucose Control System. Intervention: For glucose measurement, a sample of blood gas will be taken every 30 minutes. Actrapid HM will be used in a 4IU/ ml concentration for infusion in a 50 ml syringe. The range of glucose will be recorded throughout the intra-operative period. The number of hypoglycemic (\<70mg/dl) and hyperglycemic (\> 200mg/dl) events will be recorded.

Device: Space Glucose Control

Interventions

Space Glucose Control DEVICE

Development of a closed loop control system via Space Glucose Control that automatically infuses insulin on the basis of an automated algorithm, which integrates a continuous glucose signal, could help overcome these obstacles and permit strict glycemic control without increasing the workload.

Space Glucose Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type I or type II diabetic patients from both genders aged between 40 - 75 years, who are ASA III-IV undergoing Cardiopulmonary Bypass surgery under general anesthesia for more than 4 hours and requiring the insertion of an arterial line.

You may not qualify if:

• Critically ill patients ASA V
• Pregnant patients
• Patients' refusal to consent
• Emergency or lifesaving cases

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (2)

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

• Kaddoum R, Khalili A, Shebbo FM, Ghanem N, Daher LA, Ali AB, Chehade NEH, Maroun P, Aouad MT. Automated versus conventional perioperative glycemic control in adult diabetic patients undergoing open heart surgery. BMC Anesthesiol. 2022 Jun 16;22(1):184. doi: 10.1186/s12871-022-01721-6.

  PMID: 35710339 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Anesthesiology/ Director of Pediatric Anesthesia/ Director of Operating Room

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: May 16, 2018
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

LE (1)