Improvement of Cerebrovascular Autoregulation in Patients... | NCT04259567

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

NCT04259567

Sponsor

Johannes Gutenberg University Mainz

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Septic Shock

Interventions

Cytokine absorption

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jul 31, 2022Estimated

First Submitted Date

Jan 31, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schramm, Deputy intensive care unit, Principal investigator, medical doctor, Johannes Gutenberg University MainzPrincipal Investigator

Lead Sponsor

Johannes Gutenberg University MainzOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Filter	Active Comparator	Patients with CytoSorb absorber	Device: Cytokine absorption
Control	No Intervention	Patients without CytoSorb absorber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytokine absorption	Device	Use of CytoSorb absorber	Filter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

septic shock
acute renal failure with need for renal replacement therapy

Exclusion Criteria:

pregnancy
nursing
impossibility to do transcranial Doppler ultrasound

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center of the Johannes Gutenberg-Univerity	Recruiting	Mainz		55131	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided