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

Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04259567
Acronym
SepsAR3
Enrollment
150
Registered
2020-02-06
Start date
2020-06-08
Completion date
2022-07-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Cerebrovascular Autoregulation, Septic Shock, Cytokine

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.

Interventions

DEVICECytokine absorption

Use of CytoSorb absorber

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pregnancy * nursing * impossibility to do transcranial Doppler ultrasound

Design outcomes

Primary

MeasureTime frameDescription
Differences in the index of cerebrovascular autoregulation (Mx) between both groupsdays 1 to 4 after diagnosis of septic shockIntegrity 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026