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

The Efficacy of TRH in Intensive Care patients; a dose finding study - The ETHIC Trial; Dose finding pilot study

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46988
Enrollment
16
Registered
2016-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non thyroidal illness syndrome

Interventions

Subjects will receive protirelin (TRH) intravenously until the end of their stay in the intensive care but with a minimum treatment duration of 5 days and a maximum treatment duration of 2 weeks. Up

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the change in T3 concentration after treatment with protireline.

Secondary

MeasureTime frame
The secondary endpoints of the study are thyroid hormone concentrations (T3, T4, fT4, rT3 and TSH), metabolic markers including urea, creatinine and the bone markers CTx and P1NP before, and during 1 and 2 weeks of treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)