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

• ClinicalTrials.gov Identifier: NCT04554615
• Recruitment Status: Completed
• First Posted: September 18, 2020
• Last Update Posted: March 9, 2021
• Sponsor: Tanta University
• Information provided by (Responsible Party): MOHAMMED FAWZI ALI ABOSAMAK, Tanta University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hyperglycemia; Postoperative Complications; Insulin Resistance	Drug: Insulin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
• Actual Study Start Date: September 14, 2017
• Actual Primary Completion Date: March 3, 2018
• Actual Study Completion Date: June 10, 2018

Arms and Interventions

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 Name: 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 Name: Blood sugar measurement

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Duration to control hyperglycemia [ Time Frame: 180 days ]
   the duration till stabilization of the targeted BG level
2. 28-day ICU morbidity [ Time Frame: 180 days ]
   hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.
3. 28 - day ICU mortality [ Time Frame: 180 days ]
   patients died within 28 days of ICU admission

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Saudi Arabia

Security Forces Hospital

Riyadh, Saudi Arabia

Sponsors and Collaborators

Tanta University

Investigators

• Principal Investigator: Mohammed Abosamak; Tanta University

More Information

• Responsible Party: MOHAMMED FAWZI ALI ABOSAMAK, Clinical professor of anesthesia and critical care, Tanta University
• ClinicalTrials.gov Identifier: NCT04554615
• Other Study ID Numbers: Postoperative hyperglycemia
• First Posted: September 18, 2020
• Last Update Posted: March 9, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Once approved by clinical trial.gov data will be participated

• 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

Additional relevant MeSH terms:

Insulin Resistance; Hyperglycemia; Postoperative Complications; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs