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NCT04533256 Clinical Trial

Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

Sepsis Clinical Trial

Official title:
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04533256
Other study ID # Cyto-Sepsis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2016
Est. completion date July 30, 2021

Study information
Verified date September 2021
Source Institutul Clinic Fundeni
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Hemoadsorption has been demonstrated to improve clinical and paraclinical results in critically ill patients with sepsis and septic shock. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with sepsis, on organ failure, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines Exclusion Criteria: - unsigned informed consent - duration of therapy under 12 hours - death before the three consecutive sessions

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• CytoSorb
three consecutive sessions of hemoadsorption in patients with sepsis

Locations
Country Name City State
Romania Fundeni Clinical Institute Bucharest

Sponsors (1)
Lead Sponsor Collaborator
Institutul Clinic Fundeni

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-days mortality 28-days mortality 28 days after ICU admission
Secondary severity score dynamics of SOFA score (Sequential Organ Failure Assessment) calculated as the mathematical difference in post-therapy SOFA score and pre-therapy SOFA score 3 days
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