Hyperinsulinemic Therapy in Sepsis

Study Overview
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Brief Summary
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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.

Official Title
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Hyperinsulinemic Therapy in Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Insulin
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tight Glucose Control Hyperinsulinemic Group<br> | Drug: Insulin<br>* Intravenous Hyperinsulinemic therapy<br>|
| Experimental: Non-Tight Glucose Control Hyperinsulinemic Group<br> | Drug: Insulin<br>* Intravenous Hyperinsulinemic therapy<br>|
| Active Comparator: Standard Insulin Protocol Group<br> | Drug: Insulin<br>* Standard Intravenous Insulin Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Control | Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock | During ICU stay (average one week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Insulin