Back to resultsHyperinsulinemic Therapy in Sepsis
Primary Purpose
Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Insulin
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Insulin
Eligibility Criteria
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.
Sites / Locations
- Royal Victoria Hospital
- Montreal General Hospital
- King Khalid Univesity Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Tight Glucose Control Hyperinsulinemic Group
Non-Tight Glucose Control Hyperinsulinemic Group
Standard Insulin Protocol Group
Arm Description
Outcomes
Primary Outcome Measures
Glucose Control
Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock
Secondary Outcome Measures
Inflammatory cytokines and biochemical hormonal response
Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01244178
Brief Title
Hyperinsulinemic Therapy in Sepsis
Official Title
Hyperinsulinemic Therapy in Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
peter metrakos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Sepsis, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tight Glucose Control Hyperinsulinemic Group
Arm Type
Experimental
Arm Title
Non-Tight Glucose Control Hyperinsulinemic Group
Arm Type
Experimental
Arm Title
Standard Insulin Protocol Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Intravenous Hyperinsulinemic therapy
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Standard Intravenous Insulin Therapy
Primary Outcome Measure Information:
Title
Glucose Control
Description
Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock
Time Frame
During ICU stay (average one week)
Secondary Outcome Measure Information:
Title
Inflammatory cytokines and biochemical hormonal response
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Metrakos, FRCSC
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
King Khalid Univesity Hospital
City
Riyadh
ZIP/Postal Code
11421
Country
Saudi Arabia
12. IPD Sharing Statement
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Hyperinsulinemic Therapy in Sepsis
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