Hyperinsulinemic Therapy in Sepsis

NCT01244178 | Unknown

• 1 other identifier: 10-003-GEN
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

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.

Conditions

Sepsis

Keywords

Sepsis; Insulin

Outcome Measures

Primary Outcomes (1)

• Glucose Control

  Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock

  During ICU stay (average one week)

Secondary Outcomes (1)

• Inflammatory cytokines and biochemical hormonal response

  At randomization then at 6,24, 120 hours

Study Arms (3)

Tight Glucose Control Hyperinsulinemic Group

EXPERIMENTAL

Drug: Insulin

Non-Tight Glucose Control Hyperinsulinemic Group

EXPERIMENTAL

Drug: Insulin

Standard Insulin Protocol Group

ACTIVE COMPARATOR

Drug: Insulin

Interventions

Insulin DRUG

Intravenous Hyperinsulinemic therapy

Non-Tight Glucose Control Hyperinsulinemic Group; Tight Glucose Control Hyperinsulinemic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• peter metrakos: lead

Study Sites (3)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

King Khalid Univesity Hospital

Riyadh, Riyadh Region, 11421, Saudi Arabia

Location

MeSH Terms

Conditions

Sepsis; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Metrakos, FRCSC

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery and Associate Professor in Anatomy and Cell Biology McGill University

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CA (2); SA (1)