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L'essai clinique NCT06713668 pour Choc cardiogénique, Bradycardie, Choc est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Augmented Pacing for Shock in the Cardiac Intensive Care Unit

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06713668 est un essai interventionnel pour Choc cardiogénique, Bradycardie, Choc. Son statut actuel est : en recrutement. L'étude a débuté le 22 avril 2025 et vise à recruter 25 participants. Dirigé par l'Université Vanderbilt, l'essai devrait être terminé d'ici le 22 avril 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 mai 2025.
Résumé succinct
The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is:

Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute

Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.

Titre officiel

Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial

Conditions
Choc cardiogéniqueBradycardieChoc
Autres identifiants de l'essai
  • 241410
Numéro NCT
NCT06713668
Date de début (réel)
2025-04-22
Dernière mise à jour publiée
2025-05-02
Date de fin (estimée)
2027-04-22
Inscription (estimée)
25
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Cardiogenic Shock
Bradycardia
Shock
Pacing
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Croisé
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
AutreStandard Pacing (75 bpm) then Augmented Pacing (100 bpm)
Backup pacing rate will be set to 75 bpm first then 100 bpm second
Backup Pacing Rate Change
Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A
AutreAugmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm)
Backup pacing rate will be set to 100 bpm first then 75 bpm second
Backup Pacing Rate Change
Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Cardiac Index by thermodilution
Cardiac Index measured by thermodilution (in liters per minute per meters squared)
At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Cardiac Index by Indirect Fick
0, 15, 30 minutes.
Cardiac Output by thermodilution
0, 15, 30 minutes.
Cardiac Output by indirect fick
0 ,15, 30 minutes
Central Venous Pressure
0, 15, 30 minutes
Pulmonary Artery Systolic Pressure
0, 15, 30 minutes
Pulmonary Artery Diastolic Pressure
0, 15, 30 minutes
Pulmonary Artery Pulsitility Index
0, 15, 30 minutes
Right Ventricular Stroke Work Index
0, 15, 30 minutes
Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation
0, 15, 30 minutes
Cardiac Power Index (Thermodilution and indirect fick)
0, 15, 30 minutes
Cardiac Power Output (Thermodilution and indirect fick)
0, 15, 30 minutes
Systolic Blood pressure
0, 15, 30 minutes
Diastolic Blood Pressure
0, 15, 30 minutes
Mean Arterial Pressure
0, 15, 30 minutes
Difference in vasopressor/inotrope requirements
0, 15, 30 minutes
Arrhythmia events (Atrial and Ventricular)
0, 15, 30 minutes
Percentage of PVCs
0, 15, 30 minutes
Pacing percentage (Atrial, RV or Bi-V)
0, 15, 30 minutes
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • Adults (age 18 and older)
  • Located in the CVICU
  • FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
  • Receiving a vasopressor or Inotrope for at least 4 hours
  • Average HR ≤ 75 bpm over the last hour (on Telemetry review)
  • Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.

  • Single chamber Implantable Cardiac Defibrillator
  • Sinus rhythm with a leadless pacemaker
  • Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
  • Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine > 10 mcg/min, an increase of epinephrine > 10 mcg/kg/min, or initiation of a second vasopressor
  • Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
  • Comfort-focused care or anticipated death within 24 hours
  • Mechanical circulatory support in place
  • Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
  • Non-English Speaking
Vanderbilt University Medical Center logoUniversité Vanderbilt354 essais cliniques actifs à explorer
Partie responsable de l'essai
JGarry, Investigateur principal, Cardiovascular Medicine Research Fellow, Vanderbilt University Medical Center
Contact central de l'essai
Contact: Jonah D Garry, M.D, 914-523-3933, [email protected]
1 Centres de l'essai dans 1 pays

Tennessee

Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Jonah D Garry, MD, Contact, 914-523-3933, [email protected]
En recrutement