NCT05485376

Pulmonary Artery Catheter in Cardiogenic Shock Trial

The Pulmonary Artery Catheter in Cardiogenic Shock Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.

Detailed description

The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800).

Conditions

• Cardiogenic Shock
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Pulmonary Artery Catheter	The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.

Timeline

• Start date: 2022-08-23
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-08-03
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States