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Hyperinsulinemic Therapy in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01244178
First received: November 18, 2010
Last updated: February 15, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
 Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperinsulinemic Therapy in Sepsis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Glucose Control [ Time Frame: During ICU stay (average one week) ] [ Designated as safety issue: Yes ]
    Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock


Secondary Outcome Measures:
  • Inflammatory cytokines and biochemical hormonal response [ Time Frame: At randomization then at 6,24, 120 hours ] [ Designated as safety issue: No ]
    Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock


Estimated Enrollment: 15
Study Start Date: November 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tight Glucose Control Hyperinsulinemic Group Drug: Insulin
Intravenous Hyperinsulinemic therapy
Experimental: Non-Tight Glucose Control Hyperinsulinemic Group Drug: Insulin
Intravenous Hyperinsulinemic therapy
Active Comparator: Standard Insulin Protocol Group Drug: Insulin
Standard Intravenous Insulin Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244178

Contacts
Contact: Thamer Nouh, FRCSC thamer.nouh@mail.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Thamer Nouh         thamer.nouh@mail.mcgill.ca    
Principal Investigator: Peter Goldberg, FRCPC            
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Thamer Nouh         thamer.nouh@mail.mcgill.ca    
Principal Investigator: Kosar Khwaja, FRCSC            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Peter Metrakos, FRCSC McGill University
  More Information

No publications provided

Responsible Party: Dr. Peter Metrakos, McGill University
ClinicalTrials.gov Identifier: NCT01244178     History of Changes
Other Study ID Numbers: GEN-10-003
Study First Received: November 18, 2010
Last Updated: February 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Sepsis
Insulin

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013