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NCT04392258: Thyro-CPR
Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation
trial testing TSH determination in Heart Arrest in 200 participants. Status unknown.
1 June 2022
Quick facts
| Lead sponsor | Ruhr University of Bochum |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 May 2021 |
| Primary completion | 1 June 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- TSH determination
- FT4 determination
- FT3 determination
- SPINA-GT
- SPINA-GD
Conditions studied
- Heart Arrest — all drugs for Heart Arrest →
- Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
- Ventricular Flutter — all drugs for Ventricular Flutter →
- Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
Sponsor
Ruhr University of Bochum
Who can join
18 and older, any sex, with Heart Arrest or Ventricular Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Time-limited adaptive responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardiopulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have occasionally been reported. Aim of the planned study is to investigate the thyrotropic (i.e. thyroid-controlling) partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical measures of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective sub-study (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing treatment. This includes the evaluation of additional possible predictors, too. Primary endpoint of the study is changed TSH concentration immediately after CPR compared to the TSH value 24 hours later. Secondary endpoint is the relation between thyroid-controlling pituitary function and mortality. A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increased oxygen consumption of the heart in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04392258
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04392258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruhr University of Bochum
- Last refreshed: 19 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04392258.
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