Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
- Conditions
- HyperglycemiaPostoperative ComplicationsInsulin Resistance
- Interventions
- Registration Number
- NCT04554615
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Insulin Therapy Insulin 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. Intensive Insulin Therapy Insulin 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.
- Primary Outcome Measures
Name Time Method The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level. 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
Name Time Method 28 - day ICU mortality 180 days patients died within 28 days of ICU admission
Duration to control hyperglycemia 180 days the duration till stabilization of the targeted BG level
28-day ICU morbidity 180 days hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.
Trial Locations
- Locations (1)
Security Forces Hospital
🇸🇦Riyadh, Saudi Arabia