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

NCT06476860 | Active Not Recruiting

• 1 other identifier: GHT_CHIM RNI20221130
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis and Septic Shock

Keywords

proteinuria; septic shock; sepsis; Acute Respiratory Distresse Syndrome

Outcome Measures

Primary Outcomes (1)

• Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock.

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

  24 hours

Secondary Outcomes (3)

• measurement of albuminuria urinary IgG at H0 and H24

  24 hours

• measurement of alpha-1-microglobulin at H0 and H24

  24 hours

• measurement of urinary IgG at H0 and H24

  24 hours

Study Arms (1)

patients suspected of sepsis or septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients suspected of sepsis or septic shock until 100 patients are enrolled. Infection diagnosis is based on systemic clinical signs (fever) or local inflammatory signs, biological evidence, and suspicion or confirmation of an infectious agent. The diagnosis of sepsis involves infection accompanied by organ failure, which may manifest as cardiovascular, respiratory, neurological, metabolic, renal, coagulation, or hepatic impairment. These signs may precede hypotension or occur without it.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal André Grégoire: lead

Study Sites (1)

CHI Andre Gregoire

Montreuil, 93100, France

Location

Related Publications (1)

• Iba T, Levy JH. Derangement of the endothelial glycocalyx in sepsis. J Thromb Haemost. 2019 Feb;17(2):283-294. doi: 10.1111/jth.14371. Epub 2019 Feb 3.

  PMID: 30582882 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic; Proteinuria

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 27, 2024
• Study Start: May 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-05

Locations

FR (1)