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

Phase 1

• Conditions: on thyroidal illness syndrome; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-001006-41-NL
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Aged =18
Admitted to the ICU for at least 1 week prior to inclusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

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)
?Previous, but not current, glucocorticoid use in which the final dose was
administered within =48 hours prior to study start.
?Renal failure requiring dialysis or hemofiltration
?Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the minimal dose of protirelin that is effective and safe to normalize plasma thyroid hormone levels in patients with prolonged critical illness;Secondary Objective: To determine whether treatment of non thyroidal illness syndrome using protirelin affects metabolic parameters in critically ill patients;Primary end point(s): The primary endpoint of the study is the combination of plasma thyroid hormone levels (T3, T4, fT4, rT3 and TSH) before, during and after treatment with protirelin;Timepoint(s) of evaluation of this end point: Plasma thyroid hormones will be assessed daily <br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Metabolic markers including urea, creatinine and the bone markers CTx and P1NP before, during and after treatment with protirelin;Timepoint(s) of evaluation of this end point: Daily