Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy (SepsAR2)

June 9, 2020 updated by: Patrick Schramm, Johannes Gutenberg University Mainz

Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • University Medical Center of the Johannes Gutenberg-Univerity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodialysis
Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis
Procedure: continuous veno-venous hemodialysis
Other Names:
  • Renal replacement therapy
No hemodialysis
Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Patrick Schramm, MD, Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

August 17, 2013

First Submitted That Met QC Criteria

August 17, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83743712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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