SepsisNCT01244178
Hyperinsulinemic Therapy in Sepsis
A study testing Insulin in people with Sepsis, run by peter metrakos at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Saudi Arabia1 site
King Khalid Univesity Hospital
Riyadh, Riyadh Region, 11421
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tight Glucose Control Hyperinsulinemic Group | Experimental | Not described Receives: Drug: Insulin |
| Non-Tight Glucose Control Hyperinsulinemic Group | Experimental | Not described Receives: Drug: Insulin |
| Standard Insulin Protocol Group | Active comparator | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Control
Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock
Measured: During ICU stay (average one week)
Secondary outcomes (1)
Inflammatory cytokines and biochemical hormonal response
Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock
Measured: At randomization then at 6,24, 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- peter metrakos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, peter metrakos, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Peter Metrakos, FRCSC, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244178
- Sponsor's protocol ID
- 10-003-GEN
- Status last verified
- Oct 2013
- First submitted
- 18 Nov 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperinsulinemic Therapy in Sepsis
- ClinicalTrials.gov ID
- NCT01244178
- Acronym / sponsor ID
- 10-003-GEN
- Conditions
- Sepsis
- Keywords
- Sepsis, Insulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- peter metrakosUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tight Glucose Control Hyperinsulinemic Group | Experimental | Drug: Insulin |
| Non-Tight Glucose Control Hyperinsulinemic Group | Experimental | Drug: Insulin |
| Standard Insulin Protocol Group | Active comparator | Drug: Insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinIntravenous Hyperinsulinemic therapy | Drug | Non-Tight Glucose Control Hyperinsulinemic Group, Tight Glucose Control Hyperinsulinemic Group |
| InsulinStandard Intravenous Insulin Therapy | Drug | Standard Insulin Protocol Group |
Primary outcome
Glucose Control
Time frame: During ICU stay (average one week)
Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock
1 secondary outcome
Inflammatory cytokines and biochemical hormonal response
Time frame: At randomization then at 6,24, 120 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Metrakos, FRCSC principal investigator
McGill University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Sepsis, run by peter metrakos at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Control (time frame: During ICU stay (average one week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013; AzTrials last refreshed its copy on 30 Oct 2026.