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NCT03715556: FAARV
Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response
Phase 3 trial testing Amiodarone in Sepsis in 126 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 1 December 2018 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Amiodarone (AMIODARONE) — full drug profile →
- 0.9% physiological solution — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
- Septic Shock — all drugs for Septic Shock →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
Sponsor
University of Sao Paulo General Hospital
Who can join
18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03715556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06262932 — Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With R · Phase 4 · completed
- NCT05287191 — MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care · Phase 3 · recruiting
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Currently open trials in the same condition.
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Other University of Sao Paulo General Hospital trials
Trials by the same sponsor.
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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 NCT03715556 (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 University of Sao Paulo General Hospital
- Last refreshed: 23 October 2018
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/NCT03715556.
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