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

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

Sponsors

Lead Sponsor: Tanta University

Source Tanta University
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).

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.

Overall Status Not yet recruiting
Start Date September 14, 2020
Completion Date June 10, 2021
Primary Completion Date March 3, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level. 180 days
Secondary Outcome
Measure Time Frame
Duration to control hyperglycemia 180 days
28-day ICU morbidity 180 days
28 - day ICU mortality 180 days
Enrollment 86
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin

Description: insulin infusion to control postoperative hyperglycemia

Other Name: Blood sugar measurement

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mohammed Abosamak Principal Investigator Tanta University
Overall Contact

Last Name: Mohammed Abosamak

Phone: 00966599056616

Email: [email protected]

Location
Facility: Contact: Contact Backup: Security Forces Hospital Mohammed Abosamak 00966599056616 [email protected]
Location Countries

Saudi Arabia

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tanta University

Investigator Full Name: MOHAMMED FAWZI ALI ABOSAMAK

Investigator Title: Clinical professor of anesthesia and critical care

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Conventional Insulin Therapy

Type: Active Comparator

Description: 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.

Label: Intensive Insulin Therapy

Type: Active Comparator

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov