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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.
Tufts Medical Center
Boston, Massachusetts, United States
RECRUITINGNumber of participants who die in the hospital
Time frame: Length of stay in hospital, an average of 30 days
Number of Participants with in-hospital Cardiac Arrest
Time frame: Length of stay in hospital, an average of 30 days
Number of Participants that require Mechanical Ventilation
Time frame: Length of stay in hospital, an average of 30 days
Number of Participants that require Renal Replacement Therapy
Time frame: Within 96 hours of randomization
Length of stay in CCU or ICU
Time frame: Length of stay in hospital, an average of 30 days
Occurrence of heart transplantation and durable LVAD implantation
Time frame: Length of stay in hospital, an average of 30 days
Death
Time frame: 30 days and 6 months after discharge
Heart failure hospitalizations/emergency room visits
Time frame: 30 days and 6 months after discharge
Admission to an outpatient IV diuretic center
Time frame: 30 days and 6 months after discharge.
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