Cerebrovascular Autoregulation in Sepsis, Influence of Re... | NCT01926301

Studies
Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

NCT01926301

Sponsor

Johannes Gutenberg University Mainz

Status

Withdrawn

Last Update Posted

Jun 11, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

Interventions

continuous veno-venous hemodialysis

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 2020Actual

Completion Date

Jun 2020Actual

First Submitted Date

Aug 17, 2013

First Submission Date that Met QC Criteria

Aug 17, 2013

First Posted Date

Aug 20, 2013Estimated

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, Associate Professor, 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

Not provided

Is FDA Regulated Device

Not provided

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 cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation.

Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemodialysis		Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis	Procedure: continuous veno-venous hemodialysis
No hemodialysis		Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous veno-venous hemodialysis	Procedure		Hemodialysis	Renal replacement therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebrovascular autoregulation	Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock	during the first 4 days

Secondary Outcomes

Measure	Description	Time Frame
Delirium	Incidence of Delirium at day 4 after severe sepsis or septic shock	at day 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

severe sepsis or septic shock
adult patients
possibility of transcranial Doppler ultrasound

Exclusion Criteria:

traumatic brain injury
known cerebrovascular diseases
Infection of the brain
chronic renal failure
pregnancy

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

Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Schramm, MD	Johannes Gutenberg University Mainz	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic
D003693	Delirium

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079664	Continuous Renal Replacement Therapy
D017582	Renal Replacement Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided