HypotensionThyroidNCT00664079
Thyroid Hormones in Critically Ill Children
An observational study of Hypotension and Respiratory Failure, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Hypotension, Respiratory Failure
- What is being tested?
- Blood draws
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- Phase
- Observational
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are admitted to the Pediatric Intensive Care Unit at the Children's Hospital of Philadelphia will be approached if they meet inclusion criteria.
Who may be able to join
- Informed Consent
- Age of less than 12 months and less than or equal to 18
- Patient must weigh greater than 10 kgs.
- Patients must require vasoactive infusions and/or mechanical ventilation.
- Patients must be enrolled within 24 hours of meeting eligibility.
Who cannot join
- Patient with known or presumed pre-existing thyroid disease will be excluded
- Patients who receive thyroid supplementation will be excluded
- Patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness.
- Patients who are intubated for airway protection only.
- Patients intubated for neuromuscular disease
- Pregnant patients.
- Patients receiving amiodarone supplementation
- Patients who received blood product transfusions equaling more than 1/2 of their blood volume.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Thyroid Hormone Deficiency in Critically Ill Children
Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. We hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.
Read the detailed description
We hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. We will measure TSH, tT3, fT3, rT3, tT4, fT4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.
- Conditions
- Hypotension, Respiratory Failure
- Being tested
- Blood draws
- Keywords
- Thyroid Deficiency, Thyroid Stimulating Hormone
- Medical subject headings
- Hypotension, Respiratory Insufficiency, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Also called Critically Ill Children, Vasoactive Infusions in Children, Mechanical Venilation in Children, Thyroid Deficiency
17 mls of blood will be drawn over a 5 day period from either a central venous catheter/arterial line or with scheduled phlebotomy. The following labs will be run tT3, fT3, rT#, tT4, fT4, TSH, and tyrosine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who are receiving vasoactive medications and/or are mechanically ventilated. Receives: Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Certain critically ill children requiring vasoactive infusions and/or mechanical ventilation have low concentrations of tT3, fT3, tT4, fT4, elevated rT3, adn inappropriate low/normal TSH.
Measured: When patient has completed the study.
Secondary outcomes (2)
Critically ill children with more severe thyroid hormone deficiencies will have greater severity of illness, intensity of therapeutic intervention, organ dysfunction, and increased morbidity and mortality.
Measured: When study is completed.
Critically ill children requiring vasoactive infusions and/or mechanical ventilation are a population in the ICU that has thyroid hormone pertubation and significant morbidity and mortality.
Measured: At completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionDec 2008
Why it stopped: Sluggish enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athena Zuppa, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664079
- Sponsor's protocol ID
- 2005-10-4547
- Acronym
- Thyroid
- Status last verified
- Jul 2008
- First submitted
- 18 Apr 2008
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormone Deficiency in Critically Ill Children
- ClinicalTrials.gov ID
- NCT00664079
- Acronym / sponsor ID
- Thyroid / 2005-10-4547
- Conditions
- Hypotension, Respiratory Failure
- Keywords
- Thyroid Deficiency, Thyroid Stimulating Hormone
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sluggish enrollment.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Apr 2008 (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.
Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. We hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.
Detailed description
We hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. We will measure TSH, tT3, fT3, rT3, tT4, fT4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood drawsPatients who are receiving vasoactive medications and/or are mechanically ventilated. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are admitted to the Pediatric Intensive Care Unit at the Children's Hospital of Philadelphia will be approached if they meet inclusion criteria.
Key inclusion criteria (5 listed)
- Informed Consent
- Age of less than 12 months and less than or equal to 18
- Patient must weigh greater than 10 kgs.
- Patients must require vasoactive infusions and/or mechanical ventilation.
- Patients must be enrolled within 24 hours of meeting eligibility.
Key exclusion criteria (8 listed)
- Patient with known or presumed pre-existing thyroid disease will be excluded
- Patients who receive thyroid supplementation will be excluded
- Patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness.
- Patients who are intubated for airway protection only.
- Patients intubated for neuromuscular disease
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 |
|---|---|---|
| Blood drawsAlso: Critically Ill Children, Vasoactive Infusions in Children, Mechanical Venilation in Children, Thyroid Deficiency17 mls of blood will be drawn over a 5 day period from either a central venous catheter/arterial line or with scheduled phlebotomy. The following labs will be run tT3, fT3, rT#, tT4, fT4, TSH, and tyrosine. | Other | 1 |
Primary outcome
Certain critically ill children requiring vasoactive infusions and/or mechanical ventilation have low concentrations of tT3, fT3, tT4, fT4, elevated rT3, adn inappropriate low/normal TSH.
Time frame: When patient has completed the study.
2 secondary outcomes
Critically ill children with more severe thyroid hormone deficiencies will have greater severity of illness, intensity of therapeutic intervention, organ dysfunction, and increased morbidity and mortality.
Time frame: When study is completed.
Critically ill children requiring vasoactive infusions and/or mechanical ventilation are a population in the ICU that has thyroid hormone pertubation and significant morbidity and mortality.
Time frame: At completion of study
Results and safety
The study was stopped early (reason given: Sluggish enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
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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.
Athena Zuppa, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Respiratory Failure, run by Children's Hospital of Philadelphia 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Mar 2015. 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 was stopped early (reason given: Sluggish enrollment.). 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?
Certain critically ill children requiring vasoactive infusions and/or mechanical ventilation have low concentrations of tT3, fT3, tT4, fT4, elevated rT3, adn inappropriate low/normal TSH. (time frame: When patient has completed the study.). 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 12 Mar 2015.