Hyperinsulinemic Therapy in Sepsis

Not Applicable

• Conditions: Sepsis
• Interventions: Drug: Insulin

• Registration Number: NCT01244178
• Lead Sponsor: peter metrakos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non-Tight Glucose Control Hyperinsulinemic Group	Insulin	-
Tight Glucose Control Hyperinsulinemic Group	Insulin	-
Standard Insulin Protocol Group	Insulin	-

Primary Outcome Measures

Name	Time	Method
Glucose Control	During ICU stay (average one week)	Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokines and biochemical hormonal response	At randomization then at 6,24, 120 hours	Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock

Trial Locations

Locations (3)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

King Khalid Univesity Hospital; 🇸🇦 Riyadh, Saudi Arabia