Hyperinsulinemic Therapy in Sepsis
This trial is active, not recruiting.
|Start date||November 2010|
|End date||December 2013|
|Trial size||15 participants|
|Trial identifier||NCT01244178, 10-003-GEN|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
time frame: During ICU stay (average one week)
Inflammatory cytokines and biochemical hormonal response
time frame: At randomization then at 6,24, 120 hours
Male or female participants at least 18 years old.
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.
|Official title||Hyperinsulinemic Therapy in Sepsis|
|Principal investigator||Peter Metrakos, FRCSC|
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