Thyroid DiseasesNCT03157466
Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
An observational study of Thyroid Diseases and Respiratory Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases, Respiratory Failure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the intensive care unit and mechanically ventilated for more than 48 hours who fail weaining from ventilator and with a diagnosis of nonthyroidal illness syndrome
Who may be able to join
- Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome
Who cannot join
- • age <18 yr;
- pregnancy or estro-progestinic therapy;
- tracheostomy;
- neurological or neuromuscular pathology and/or known phrenic nerve dysfunction;
- previously diagnosed intrinsic thyroid disease; known or suspected pituitary-hypothalamic disease;
- severe obesity;
Show all 12Show fewer
- ischemic cardiopathy; complex ventricular arrhythmias;
- serum cortisol level below 80 ng/ml; renal or hepatic failure (respectively, creatininemia ≥ 3.5 mg/dL and bilirubinemia ≥ 6.0 mg/dL);
- transfusion of plasma within 48 h prior to thyroid hormone assessment; use of amiodarone in the previous 8 weeks;
- use of iodine contrast agents in the previous 8 weeks;
- hemodialysis;
- expected poor outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study
Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure.
The aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.
- Conditions
- Thyroid Diseases, Respiratory Failure
- Medical subject headings
- Thyroid Diseases, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours
Measured: 24 hours (study points at 3, 6, and 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Oct 2017
- Primary completion1 May 2018
- Study completion1 May 2018
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 Thyroid DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BELLO GIUSEPPE, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157466
- Sponsor's protocol ID
- 002
- Status last verified
- Sep 2022
- First submitted
- 12 May 2017
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bello G, Spinazzola G, Giammatteo V, Montini L, De Pascale G, Bisanti A, Annetta MG, Troiani E, Bianchi A, Pontecorvi A, Pennisi MA, Conti G, Antonelli M. Effects of Thyroid Hormone Treatment on Diaphragmatic Efficiency in Mechanically Ventilated Subjects With Nonthyroidal Illness Syndrome. Respir Care. 2019 Oct;64(10):1199-1207. doi: 10.4187/respcare.06770. Epub 2019 Apr 23.
PubMed 31015389
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study
- ClinicalTrials.gov ID
- NCT03157466
- Acronym / sponsor ID
- 002
- Conditions
- Thyroid Diseases, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure.
The aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit and mechanically ventilated for more than 48 hours who fail weaining from ventilator and with a diagnosis of nonthyroidal illness syndrome
Key inclusion criteria (1 listed)
- Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome
Key exclusion criteria (12 listed)
- • age <18 yr;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours
Time frame: 24 hours (study points at 3, 6, and 24 hours)
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 6 Sep 2022.
- Derived from this study: PubMed 31015389Bello G, Spinazzola G, Giammatteo V, Montini L, De Pascale G, Bisanti A, Annetta MG, Troiani E, Bianchi A, Pontecorvi A, Pennisi MA, Conti G, Antonelli M. Effects of Thyroid Hormone Treatment on Diaphragmatic Efficiency in Mechanically Ventilated Subjects With Nonthyroidal Illness Syndrome. Respir Care. 2019 Oct;64(10):1199-1207. doi: 10.4187/respcare.06770. Epub 2019 Apr 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyroid Diseases and Respiratory Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 12 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 6 Sep 2022. 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 Italy. 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?
Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours (time frame: 24 hours (study points at 3, 6, and 24 hours)). 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 NCT03157466, 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 6 Sep 2022.