Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU

The current study hypothesizes that the use of Intravenous intensive insulin therapy (IV-IIT) may be beneficial than IV conventional insulin therapy (IV-CIT) for improving the outcome of non-diabetic surgical patients had postoperative (PO) stress hyperglycemia (PSH).

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Postoperative Complications; Insulin Resistance
• Intervention / Treatment: Drug: Insulin

Detailed Description

All postoperative patients who will be admitted to surgical ICU and develop (PSH) will be eligible for evaluation for inclusion and exclusion criteria.

Prior to initiation of IV-IT (insulin therapy), blood samples will be obtained to estimate base-line Blood Glucose level (BG). BG will be estimated hourly during IV-IT to guard against development of hypoglycemic episodes. The assigned IV-IT will continue till reaching the target BG for each group and then will be stopped and patients will be shifted to subcutaneous (sc)-IT. During maintenance sc-IT, BG level will be estimated 6-hourly to assure maintenance of BG within the desired range, otherwise if hyperglycemia recurred or its induced complications as hyperglycemic ketoacidosis or hyperosmolar coma or infectious complications developed, IV-IT will be resumed and BG will be followed-up hourly. The same sequence of follow-up will be continued till stability of BG at the targeted level. IV-IT will be provided as following :

Conventional insulin therapy (CIT) will be provided as a continuous infusion of 50 IU of Actrapid HM in 50 ml of 0.9% sodium chloride using a pump. Infusion will be adjusted to achieve BG level in range of 180-200 mg/dl.

Intensive insulin therapy (IIT) will be provided as an insulin infusion at rate of 1 mU/kg/min and will be adjusted to achieve target BG level in range of 80-110 mg/dl.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Security Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All postoperative patients who will be admitted to surgical ICU and developed Post Surgical Hyperglycemia will be eligible for evaluation for inclusion and exclusion criteria

Exclusion Criteria:

• All patients having diabetes mellitus, history of preoperative stress hyperglycemia, endocrinopathies, obesity defined as body mass index (BMI) >30 kg/m2, age younger than 18 years, renal impairment or maintenance on renal replacement therapy and liver diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Insulin Therapy; CIT was provided as a continuous infusion of 50 IU of Actrapid HM in 50 ml of 0.9% sodium chloride using a pump, Infusion was adjusted to achieve BG level in range of 180-200 mg/dl.	Drug: Insulin; insulin infusion to control postoperative hyperglycemia; Other Names: Blood sugar measurement
ACTIVE_COMPARATOR: Intensive Insulin Therapy; IIT was provided as an insulin infu-sion at rate of 1 mU/kg/min and was adjusted to achieve target BG level in range of 80-110 mg/dl.	Drug: Insulin; insulin infusion to control postoperative hyperglycemia; Other Names: Blood sugar measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level.	insulin infusion will be given in shots to control the high blood sugar and the times of giving these shots will be counted	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration to control hyperglycemia	the duration till stabilization of the targeted BG level	180 days
28-day ICU morbidity	hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.	180 days
28 - day ICU mortality	patients died within 28 days of ICU admission	180 days

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed Abosamak, Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2017
• Primary Completion (ACTUAL): March 3, 2018
• Study Completion (ACTUAL): June 10, 2018

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Hyperglycemia; Insulin Resistance; Postoperative Complications; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: Postoperative hyperglycemia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Once approved by clinical trial.gov data will be participated

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No