The Efficacy of TRH in Intensive Care patients; a dose finding study

Phase 2

Withdrawn

• Conditions: Non thyroidal illness syndrome; changes in thyroidhormone metabolism due to non thyroid related illness; 10021112

• Registration Number: NL-OMON46988
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Aged *18
Admitted to the ICU for at least 1 week prior to inclusion
Expected duration of further stay *5 days
Systemic treatment with morphine or other opioids

Exclusion Criteria

* Known pre-existing thyroid disease
* Treatment with drugs aimed at restoring biochemical euthyroidsm
(methimazole, propylthiouracil, triiodothyronine and levothyroxine) and amiodarone.
* Treatment with heparine at a therapeutic (thrombolytic) dose (*10.000
IE/24h)
* Treatment with somatostatin or dopaminergic drugs
* Current glucocorticoid use or glucocorticoid use within *48 hours prior to study start
* Renal failure requiring dialysis or hemofiltration
* Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the change in T3 concentration after<br /><br>treatment with protireline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the study are thyroid hormone concentrations (T3,<br /><br>T4, fT4, rT3 and TSH), metabolic markers including urea, creatinine and the<br /><br>bone markers CTx and P1NP before, and during 1 and 2 weeks of treatment.</p><br>