Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT04963920
Status:
SUSPENDED
Last Update Posted:
2025-08-05
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock
Sponsor:
CytoSorbents Europe GmbH
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multicenter, Single-blind, Controlled Study to Assess the Performance of the Cytosorb® 300 ml Device for Shock Reversal in Patients With Vasoplegic Septic Shock
Status:
SUSPENDED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment for the study is currently on hold to allow for a protocol amendment. This revision aims to align the study design with changes in clinical practice since the trial's initiation.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROCYSS
Brief Summary:
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: