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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04554615
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
8.8
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Mar 3, 2018
Actual Study Completion Date :
Jun 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional Insulin Therapy

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.

Drug: Insulin
insulin infusion to control postoperative hyperglycemia
Other Names:
  • Blood sugar measurement

    		•
    Active Comparator: Intensive Insulin Therapy

    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.

    Drug: Insulin
    insulin infusion to control postoperative hyperglycemia
    Other Names:
  • Blood sugar measurement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Duration to control hyperglycemia [180 days]

      the duration till stabilization of the targeted BG level

    2. 28-day ICU morbidity [180 days]

      hyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.

    3. 28 - day ICU mortality [180 days]

      patients died within 28 days of ICU admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Security Forces Hospital Riyadh Saudi Arabia

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Mohammed Abosamak, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MOHAMMED FAWZI ALI ABOSAMAK, Clinical professor of anesthesia and critical care, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04554615
    Other Study ID Numbers:
    • Postoperative hyperglycemia
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Insulin Resistance
    Hyperglycemia
    Postoperative Complications
    Insulin

    Study Results

    No Results Posted as of Mar 9, 2021