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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157466
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Giuseppe Bello, 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.


Condition or disease
Thyroid Diseases Respiratory Failure

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours [ Time Frame: 24 hours (study points at 3, 6, and 24 hours) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157466


Locations
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Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Giuseppe Bello, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03157466     History of Changes
Other Study ID Numbers: 002
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Thyroid Diseases
Euthyroid Sick Syndromes
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs