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NCT03735693: FIBER
Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
trial testing Ulstrasound in Amyotrophia in 60 participants. Terminated before completion.
14 December 2021
Quick facts
| Lead sponsor | Association Pro-arte |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 14 September 2018 |
| Primary completion | 14 December 2021 |
| Estimated completion | 2 February 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Ulstrasound
Conditions studied
- Amyotrophia — all drugs for Amyotrophia →
- Weakness, Muscle — all drugs for Weakness, Muscle →
Sponsor
Association Pro-arte
Who can join
Adults 18 to 80, any sex, with Amyotrophia or Weakness, Muscle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. The amyotrophy can be reliably evaluated by measuring the cross-sectional area of the right femoral muscle. The hypothesis is that amyotrophy measured by muscle ultrasound can allow an early and reliable diagnosis of neuromuscular weakness syndrome (NMWS), even though the measurement of the MRC score (the Gold Standard), has shown its limitations in intensive care in terms of reliability and delayed diagnosis. Moreover, this syndrome is associated with a loss of functionality and a deterioration of long-term quality of life. One of the objectives is thus to determine if the muscular ultrasound allows a prediction of the occurrence of these alterations far from the intensive care. Early rehabilitation has shown a benefit on mortality, duration of stay, mechanical ventilation and on functional alteration after intensive care. This is why an earlier and more precise means of diagnostic of this pathology is searched. The target population is therefore patients from 18 to 80 years hospitalized in intensive care for prolonged stay (\> 5 days), and prolonged ventilation (\> 48H).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT03735693
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Related trials
Other Association Pro-arte trials
Trials by the same sponsor.
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- NCT03823430 — Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? · completed
- NCT03736239 — Ultrasound Study of the Diaphragm Evolution Under ECMO · completed
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 NCT03735693 (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 Association Pro-arte
- Last refreshed: 3 February 2023
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/NCT03735693.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing