Hyperinsulinemic Therapy in Sepsis

peter metrakos15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sepsis

Interventions

InsulinDRUG

Intravenous Hyperinsulinemic therapy

InsulinDRUG

Standard Intravenous Insulin Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Royal Victoria Hospital

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

King Khalid Univesity Hospital

Riyadh, Riyadh Region, Saudi Arabia

Outcomes

Primary Outcomes

Glucose Control

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

Time frame: During ICU stay (average one week)

Secondary Outcomes

Inflammatory cytokines and biochemical hormonal response

Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock

Time frame: At randomization then at 6,24, 120 hours

Data from ClinicalTrials.gov

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