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Hyperinsulinemic Therapy in Sepsis

NCT ID: NCT01244178

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Keywords

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Sepsis Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tight Glucose Control Hyperinsulinemic Group

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Intravenous Hyperinsulinemic therapy

Non-Tight Glucose Control Hyperinsulinemic Group

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Intravenous Hyperinsulinemic therapy

Standard Insulin Protocol Group

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Standard Intravenous Insulin Therapy

Interventions

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Insulin

Intravenous Hyperinsulinemic therapy

Intervention Type DRUG

Insulin

Standard Intravenous Insulin Therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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peter metrakos

OTHER

Sponsor Role lead

Responsible Party

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peter metrakos

Associate Professor of Surgery and Associate Professor in Anatomy and Cell Biology McGill University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Metrakos, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

King Khalid Univesity Hospital

Riyadh, Riyadh Region, Saudi Arabia

Site Status

Countries

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Canada Saudi Arabia

Other Identifiers

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10-003-GEN

Identifier Type: -

Identifier Source: org_study_id