Viewing Study NCT06476860


Ignite Creation Date: 2025-12-25 @ 2:13 AM
Ignite Modification Date: 2026-02-22 @ 4:51 PM
Study NCT ID: NCT06476860
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-05-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS
Sponsor: Centre Hospitalier Intercommunal André Grégoire
Organization:

Study Overview

Official Title: Proteinuria During Sepsis and Septic Shock: Characterization and Association With Acute Respiratory Distress Syndrome
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ALBUREA
Brief Summary: ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.
Detailed Description: Septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. These failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. Pulmonary failure secondary to septic shock is characterized by edema, with ARDS being the most severe form. Sepsis is the second most common cause of ARDS after pneumonia. The incidence of ARDS in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality.

These failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. Conversely, the onset of ARDS onset warrants limiting hydro-sodium inputs. Currently, there are no data predicting the occurrence of ARDS patients with septic shock.

Study Oversight

Has Oversight DMC: None
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?: None
Is an FDA AA801 Violation?: