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

Completed

• Conditions: Thyroid Diseases; Respiratory Failure

• Registration Number: NCT03157466
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-10-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy