Hyperinsulinemic Therapy in Sepsis

October 24, 2013 updated by: peter metrakos

Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is a protocol for Insulin administration that involves the administration of a calculated higher dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has been shown to be safe and successful in maintaining normal glucose levels.

The objective of the study is to assess if the clamp can achieve a steady and normal blood glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if the higher insulin dose would lead to a drop in the inflammatory response seen in septic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11421
        • King Khalid Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.

Exclusion Criteria:

  • Age less than 18 years old.
  • Pregnancy.
  • Patients who cannot provide informed consent and there is no surrogate decision maker.
  • A delay of more than 24 hours between eligibility and randomization.
  • Patients admitted to the intensive care unit for treatment of diabetic ketoacidosis or hyperosmolar state.
  • Imminent death.
  • Patients who the treating clinicians are not committed to full supportive care. This is confirmed by a documented treatment-limitation order that exceeds a "do-not-resuscitation" order.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tight Glucose Control Hyperinsulinemic Group
Drug: Insulin
Intravenous Hyperinsulinemic therapy
Drug: Insulin
Standard Intravenous Insulin Therapy
EXPERIMENTAL: Non-Tight Glucose Control Hyperinsulinemic Group
Drug: Insulin
Intravenous Hyperinsulinemic therapy
Drug: Insulin
Standard Intravenous Insulin Therapy
ACTIVE_COMPARATOR: Standard Insulin Protocol Group
Drug: Insulin
Intravenous Hyperinsulinemic therapy
Drug: Insulin
Standard Intravenous Insulin Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Control
Time Frame: During ICU stay (average one week)
Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock
During ICU stay (average one week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokines and biochemical hormonal response
Time Frame: At randomization then at 6,24, 120 hours
Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock
At randomization then at 6,24, 120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

peter metrakos

Investigators

  • Principal Investigator: Peter Metrakos, FRCSC, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (ESTIMATE)

November 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-003-GEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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