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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157466
• Other study ID #: 002
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Euthyroid Sick Syndromes
• Respiratory Failure
• Respiratory Insufficiency
• Thyroid Diseases

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)