Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS

Active, not recruiting

• Conditions: Sepsis and Septic Shock

• Registration Number: NCT06476860
• Lead Sponsor: Centre Hospitalier Intercommunal André Grégoire

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 Timeline

• Study Start: 2023-05-23
• Status Verified: 2024-05
• Study First Submitted: 2024-05-30
• Primary Completion: 2024-06
• Study Completion: 2024-06
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock.

Exclusion Criteria

• Minors or opposition to participation.
• Chronic dialysis patients
• Organ transplant recipients
• Confirmed urinary tract infection
• Subject with macroscopic hematuria
• Pregnant woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock.	24 hours	relationship between proteinuria kinetics in the first 24 hours (H0 and H24) of septic shock and presence of ARDS at H72

Secondary Outcome Measures

Name	Time	Method
measurement of albuminuria urinary IgG at H0 and H24	24 hours	Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality
measurement of alpha-1-microglobulin at H0 and H24	24 hours	Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality
measurement of urinary IgG at H0 and H24	24 hours	Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality

Trial Locations

Locations (1)

CHI Andre Gregoire; 🇫🇷 Montreuil, France