Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination (SepsAR3)

Johannes Gutenberg University (JGU)

Status: Unknown

Conditions: Septic Shock

Treatments: Device: Cytokine absorption

Study type: Interventional

Funder types: Other

Identifiers

NCT04259567

V1.0_2019_06_28

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy
• nursing
• impossibility to do transcranial Doppler ultrasound

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Filter

Active Comparator group

Description:

Patients with CytoSorb absorber

Treatment:

Device: Cytokine absorption

Control

No Intervention group

Description:

Patients without CytoSorb absorber