Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
Primary Purpose
Hyperglycemia, Postoperative Complications, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia
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.
Sites / Locations
- Security Forces Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional Insulin Therapy
Intensive Insulin Therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration to control hyperglycemia
the duration till stabilization of the targeted BG level
28-day ICU morbidity
hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.
28 - day ICU mortality
patients died within 28 days of ICU admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04554615
Brief Title
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
Official Title
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
March 3, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Postoperative Complications, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Insulin Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Intensive Insulin Therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Blood sugar measurement
Intervention Description
insulin infusion to control postoperative hyperglycemia
Primary Outcome Measure Information:
Title
The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level.
Description
insulin infusion will be given in shots to control the high blood sugar and the times of giving these shots will be counted
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Duration to control hyperglycemia
Description
the duration till stabilization of the targeted BG level
Time Frame
180 days
Title
28-day ICU morbidity
Description
hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.
Time Frame
180 days
Title
28 - day ICU mortality
Description
patients died within 28 days of ICU admission
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abosamak
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once approved by clinical trial.gov data will be participated
Learn more about this trial
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
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