SepsisNCT00282594
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
A study testing Novolin R (human recombinant Insulin) in people with Sepsis and Respiratory Failure, run by Genesys at 1 site in United States.
Trial summary
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Respiratory Failure, Renal Failure
- What is being tested?
- Novolin R (human recombinant Insulin)
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2005
- 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
None listed.
Who cannot join
- Under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.
Read the detailed description
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population
- Conditions
- Sepsis, Respiratory Failure, Renal Failure, Surgical Site Infection
- Being tested
- Novolin R (human recombinant Insulin)
- Keywords
- Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control
- Medical subject headings
- Sepsis, Respiratory Insufficiency, Renal Insufficiency, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novolin R (human recombinant Insulin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Secondary outcomes (5)
Length of ICU Stay
Ventilatory Requirement
Vasopressor Support
Incidence of Renal Failure
Incidence of Wound Infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJul 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants
Sponsor and investigators
- Lead sponsor
- Genesys
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- Michael Kia, DO, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282594
- Sponsor's protocol ID
- GRMC 050023
- Status last verified
- Nov 2005
- First submitted
- 26 Jan 2006
- Last updated
- 27 Jan 2006
- Results posted
- No
Publications
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.
- ClinicalTrials.gov ID
- NCT00282594
- Acronym / sponsor ID
- GRMC 050023
- Conditions
- Sepsis, Respiratory Failure, Renal Failure, Surgical Site Infection
- Keywords
- Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants
- Lead sponsor
- GenesysUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jul 2003
- Study completion
- Oct 2005
- First posted
- 27 Jan 2006 (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.
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.
Detailed description
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Under age 18
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 |
|---|---|---|
| Novolin R (human recombinant Insulin) | Drug | – |
Primary outcome
Mortality
5 secondary outcomes
Length of ICU Stay
Ventilatory Requirement
Vasopressor Support
Incidence of Renal Failure
Incidence of Wound Infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2006.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
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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.
Michael Kia, DO principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novolin R (human recombinant Insulin) in people with Sepsis and Respiratory Failure, run by Genesys at 1 site in United States.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282594, which also lists 1 linked publication.
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 27 Jan 2006.