Hyperinsulinemic Therapy in Sepsis

Sepsis Clinical Trial

Official title:

Hyperinsulinemic Therapy in Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01244178
• Other study ID #: 10-003-GEN
• Status: Active, not recruiting
• Phase: N/A
• First received: November 18, 2010
• Last updated: October 24, 2013
• Start date: November 2010

Study information

• Verified date: October 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Insulin
Intravenous Hyperinsulinemic therapy
• Insulin
Standard Intravenous Insulin Therapy

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Saudi Arabia	King Khalid Univesity Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
peter metrakos

Countries where clinical trial is conducted

Canada,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Control	Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock	During ICU stay (average one week)	Yes
Secondary	Inflammatory cytokines and biochemical hormonal response	Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock	At randomization then at 6,24, 120 hours	No