NCT04533256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

5.1 years

First QC Date

August 26, 2020

Last Update Submit

September 3, 2021

Conditions

Sepsis

Keywords

organ failurerenal replacement therapyhemoadsorption

Outcome Measures

Primary Outcomes (1)

  • 28-days mortality

    28-days mortality

    28 days after ICU admission

Secondary Outcomes (1)

  • severity score

    3 days

Interventions

CytoSorbPROCEDURE

three consecutive sessions of hemoadsorption in patients with sepsis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.

You may qualify if:

  • patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines

You may not qualify if:

  • unsigned informed consent
  • duration of therapy under 12 hours
  • death before the three consecutive sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dana Tomescu, Prof

    Fundeni Clinical Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 31, 2020

Study Start

July 10, 2016

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

RO(1)