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

NCT ID: NCT06476860

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Sepsis and Septic Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients suspected of sepsis or septic shock

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal André Grégoire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Andre Gregoire

Montreuil, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30582882 (View on PubMed)

Other Identifiers

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GHT_CHIM RNI20221130

Identifier Type: -

Identifier Source: org_study_id

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