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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554615
• Other study ID #: Postoperative hyperglycemia
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: June 10, 2018

Study information

• Verified date: March 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 10, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Insulin Resistance
• Postoperative Complications

Intervention

Drug:
• Insulin
insulin infusion to control postoperative hyperglycemia

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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