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

NCT04554615 | Completed DMC

• 1 other identifier: Postoperative hyperglycemia
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hyperglycemia; Postoperative Complications; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration to control hyperglycemia

  180 days

• 28-day ICU morbidity

  180 days

• 28 - day ICU mortality

  180 days

Study Arms (2)

Conventional Insulin Therapy

ACTIVE COMPARATOR

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

Intensive Insulin Therapy

ACTIVE COMPARATOR

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

Interventions

Insulin DRUG

insulin infusion to control postoperative hyperglycemia

Also known as: Blood sugar measurement

Conventional Insulin Therapy; Intensive Insulin Therapy

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Hyperglycemia; Postoperative Complications; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

• Mohammed Abosamak

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of anesthesia and critical care

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 18, 2020
• Study Start: September 14, 2017
• Primary Completion: March 3, 2018
• Study Completion: June 10, 2018
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

SA (1)