NCT04259567

Brief Summary

The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

January 31, 2020

Last Update Submit

June 9, 2020

Conditions

Septic Shock

Keywords

Cerebrovascular AutoregulationSeptic ShockCytokine

Outcome Measures

Primary Outcomes (1)

  • Differences in the index of cerebrovascular autoregulation (Mx) between both groups

    Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant.

    days 1 to 4 after diagnosis of septic shock

Study Arms (2)

Filter

ACTIVE COMPARATOR

Patients with CytoSorb absorber

Device: Cytokine absorption

Control

NO INTERVENTION

Patients without CytoSorb absorber

Interventions

Cytokine absorptionDEVICE

Use of CytoSorb absorber

Filter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock
  • acute renal failure with need for renal replacement therapy

You may not qualify if:

  • pregnancy
  • nursing
  • impossibility to do transcranial Doppler ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of the Johannes Gutenberg-Univerity

Mainz, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy intensive care unit, Principal investigator, medical doctor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

June 8, 2020

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)