Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome

NCT ID: NCT03157466

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Diseases Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome

Exclusion Criteria

* • 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;
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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BELLO GIUSEPPE

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 31015389 (View on PubMed)

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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