Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04554615
Enrollment
86
Registered
2020-09-18
Start date
2017-09-14
Completion date
2018-06-10
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Insulin Resistance, Postoperative Complications

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.

Interventions

DRUGInsulin

insulin infusion to control postoperative hyperglycemia

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level.180 daysinsulin infusion will be given in shots to control the high blood sugar and the times of giving these shots will be counted

Secondary

MeasureTime frameDescription
Duration to control hyperglycemia180 daysthe duration till stabilization of the targeted BG level
28-day ICU morbidity180 dayshyperglycemic hyperosmolar coma, diabetic ketoacidosis and infections will be documented.
28 - day ICU mortality180 dayspatients died within 28 days of ICU admission

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026