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Hormone Therapy
High-Dose Insulin Therapy for Sepsis
N/A
Waitlist Available
Led By Peter Metrakos, FRCSC
Research Sponsored by peter metrakos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at randomization then at 6,24, 120 hours
Awards & highlights
Study Summary
This trial is assessing the feasibility, safety, and efficacy of a high-dose insulin therapy protocol in septic ICU patients in order to maintain normoglycemia and suppress the inflammatory response.
Who is the study for?
This trial is for adults with severe sepsis or septic shock admitted to the ICU. It's not for those facing imminent death, pregnant women, patients under 18, those treated for diabetic emergencies, without consent capability, or if full support care isn't planned.Check my eligibility
What is being tested?
The study tests a high-dose insulin therapy called dextrose/insulin clamp in ICU patients with sepsis. The goal is to maintain normal blood sugar and reduce inflammation caused by the body's response to infection.See study design
What are the potential side effects?
Potential side effects may include low blood sugar (hypoglycemia), which can cause shakiness, sweating, confusion and in severe cases seizures or unconsciousness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted to the ICU for severe sepsis or septic shock.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during icu stay (average one week)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during icu stay (average one week)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose Control
Secondary outcome measures
Inflammatory cytokines and biochemical hormonal response
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Tight Glucose Control Hyperinsulinemic GroupExperimental Treatment1 Intervention
Group II: Non-Tight Glucose Control Hyperinsulinemic GroupExperimental Treatment1 Intervention
Group III: Standard Insulin Protocol GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved
Find a Location
Who is running the clinical trial?
peter metrakosLead Sponsor
Peter Metrakos, FRCSCPrincipal InvestigatorMcGill University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was admitted to the ICU for severe diabetes complications.You are expected to pass away soon.I was admitted to the ICU for severe sepsis or septic shock.I cannot give consent and have no one to make decisions for me.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Tight Glucose Control Hyperinsulinemic Group
- Group 2: Non-Tight Glucose Control Hyperinsulinemic Group
- Group 3: Standard Insulin Protocol Group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left for those wishing to take part in this experimental endeavor?
"According to the clinicaltrials.gov site, this medical experiment is not presently enrolling patients. This trial was first listed on November 1st 2010 and last amended October 24th 2013; however, 242 other studies are currently recruiting participants."
Answered by AI
How many participants are eligible for inclusion in this experiment?
"Unfortunately, this clinical trial has since concluded recruitment. It was first posted on November 1st 2010 and last updated October 24th 2013. Fortunately, there are presently 170 trials actively recruiting participants with pyemia and 72 studies for Insulin that need volunteers."
Answered by AI
Are there any additional studies that have been carried out to explore the efficacy of Insulin?
"Presently, a total of 72 trials are exploring the use of Insulin with 13 being in Phase 3. While some research is being conducted out of Sao Luis, MA, there exists 248 other sites partaking in this research."
Answered by AI
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