Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination

NCT ID: NCT04259567

Last Updated: 2020-06-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Filter

Patients with CytoSorb absorber

Group Type ACTIVE_COMPARATOR

Cytokine absorption

Intervention Type DEVICE

Use of CytoSorb absorber

Control

Patients without CytoSorb absorber

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cytokine absorption

Use of CytoSorb absorber

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* nursing
* impossibility to do transcranial Doppler ultrasound
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Patrick Schramm

Deputy intensive care unit, Principal investigator, medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center of the Johannes Gutenberg-Univerity

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Patrick Schramm, MD

Role: primary

00496131176755

Other Identifiers

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V1.0_2019_06_28

Identifier Type: -

Identifier Source: org_study_id

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