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Hyperinsulinemic Therapy in Sepsis

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ClinicalTrials.gov Identifier: NCT01244178
Recruitment Status : Unknown
Verified October 2013 by peter metrakos, McGill University Health Center.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2010
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Sepsis Drug: Insulin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperinsulinemic Therapy in Sepsis
Study Start Date : November 2010
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244178

Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Saudi Arabia
King Khalid Univesity Hospital
Riyadh, Saudi Arabia, 11421
Sponsors and Collaborators
peter metrakos
Principal Investigator: Peter Metrakos, FRCSC McGill University
More Information

Responsible Party: peter metrakos, Associate Professor of Surgery and Associate Professor in Anatomy and Cell Biology McGill University, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01244178     History of Changes
Other Study ID Numbers: 10-003-GEN
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by peter metrakos, McGill University Health Center:

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs