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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
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 3, 2020
Last Updated
March 7, 2021
Sponsor
Tanta University
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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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