Clinical trial NCT03157466: Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
Official title: Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Diseases
Respiratory Failure
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 (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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours
timeFrame: 24 hours (study points at 3, 6, and 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
References:
citation: 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.