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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight Glucose Control Hyperinsulinemic Group | Experimental |
| |
| Non-Tight Glucose Control Hyperinsulinemic Group | Experimental |
| |
| Standard Insulin Protocol Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Intravenous Hyperinsulinemic therapy |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Metrakos, FRCSC | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada | ||
| Montreal General Hospital |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin | Drug | Standard Intravenous Insulin Therapy |
|
| Montreal |
| Quebec |
| H3G 1A4 |
| Canada |
| King Khalid Univesity Hospital | Riyadh | Riyadh Region | 11421 | Saudi Arabia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |