Overview

This trial is active, not recruiting.

Condition sepsis
Treatments insulin
Sponsor peter metrakos
Start date November 2010
End date December 2013
Trial size 15 participants
Trial identifier NCT01244178, 10-003-GEN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
insulin
Intravenous Hyperinsulinemic therapy
(Experimental)
insulin
Intravenous Hyperinsulinemic therapy
(Active Comparator)
insulin
Standard Intravenous Insulin Therapy

Primary Outcomes

Measure
Glucose Control
time frame: During ICU stay (average one week)

Secondary Outcomes

Measure
Inflammatory cytokines and biochemical hormonal response
time frame: At randomization then at 6,24, 120 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Hyperinsulinemic Therapy in Sepsis
Principal investigator Peter Metrakos, FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by McGill University Health Center.