Respiratory FailureNCT00247468
Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients
A study of Respiratory Failure and Cardiovascular Failure, run by Children's Hospital of Philadelphia.
Trial summary
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Respiratory Failure, Cardiovascular Failure, Sepsis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Dec 2004
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
- Invasive mechanical ventilation
- Age between 1 mo and 21 yrs
Who cannot join
- Type I diabetes mellitus
- Have an illness that requires insulin daily
- Recipients of solid organ transplants
- Participation in an experimental trial that might affect outcome
- Post-operative patients with planned extubation upon recovery
- Patients on a dopamine infusion of less than 3 mcg/kg/minute
About this study
Official title: Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.
- Conditions
- Respiratory Failure, Cardiovascular Failure, Sepsis, Trauma
- Being tested
- Strict Glucose Control
- Medical subject headings
- Respiratory Insufficiency, Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict Glucose ControlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality rate from the time of enrollment
Secondary outcomes (6)
Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
rates of nosocomial bloodstream infections
time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
change in Pediatric Logistic Organ Dysfunction scores
requirement of dialysis or hemofiltration for patients with acute renal failure
volume of blood product transfusions per kilogram body weight (vol/kg).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2004
- Study completionDec 2004
Why it stopped: Never received IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinay Nadkarni, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247468
- Sponsor's protocol ID
- 2003-2-3160
- Status last verified
- Jan 2017
- First submitted
- 1 Nov 2005
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
- ClinicalTrials.gov ID
- NCT00247468
- Acronym / sponsor ID
- 2003-2-3160
- Conditions
- Respiratory Failure, Cardiovascular Failure, Sepsis, Trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never received IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Dec 2004 (actual)
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 2 Nov 2005 (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.
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
- Invasive mechanical ventilation
- Age between 1 mo and 21 yrs
Key exclusion criteria (6 listed)
- Type I diabetes mellitus
- Have an illness that requires insulin daily
- Recipients of solid organ transplants
- Participation in an experimental trial that might affect outcome
- Post-operative patients with planned extubation upon recovery
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 |
|---|---|---|
| Strict Glucose Control | Procedure or surgery | – |
Primary outcome
30-day mortality rate from the time of enrollment
6 secondary outcomes
Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
rates of nosocomial bloodstream infections
time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
change in Pediatric Logistic Organ Dysfunction scores
requirement of dialysis or hemofiltration for patients with acute renal failure
volume of blood product transfusions per kilogram body weight (vol/kg).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Vinay Nadkarni, MD principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
A study of Respiratory Failure and Cardiovascular Failure, run by Children's Hospital of Philadelphia.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
30-day mortality rate from the time of enrollment. 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 23 Jan 2017.