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

Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03157466

Enrollment

Registered

2017-05-17

Start date

2017-10-01

Completion date

2018-05-01

Last updated

2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Thyroid Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours	24 hours (study points at 3, 6, and 24 hours)

Countries

Italy

Outcome results