Ivabradine for Heart Rate Control In Septic Shock
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Septic Shock
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multi-centre, double-blind, randomised, placebo-controlled, multi-arm multi-stage trial. The trial investigates the efficacy and safety of 2 dosing regimens of ivabradine in order to confirm the efficacy and safety of one dosing regimen for heart rate control in adult patients with septic shock.Two dosing regimens of ivabradine will be investigated in the first part and the best-performing dosing regimen will be selected for the last part of the trial. A multi-arm multi-stage (MAMS) design with 2 stages and 3 arms will be used. The trial incorporates 2 stages: 1. Activity: an interim comparison of activity using the percentage of patients with heart rate control (80-94/min) at hour-48 as primary endpoint. At the end of this stage, an interim analysis will be used in order to select the most promising ivabradine dosing protocol and compare it to placebo in the subsequent stage (pick the winner strategy). 2. Efficacy: final comparison with 28 days mortality as the primary endpoint.Masking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04031573
- Collaborators
- Not Provided
- Investigators
- Study Director: Armand MEKONTSO DESSAP, MD, PhD Assistance Publique - Hôpitaux de Paris
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