Severe SepsisSepsAR2NCT01926301
Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy
An observational study of Severe Sepsis and Septic Shock, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- continuous veno-venous hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital
Who may be able to join
- severe sepsis or septic shock
- adult patients
- possibility of transcranial Doppler ultrasound
Who cannot join
- traumatic brain injury
- known cerebrovascular diseases
- Infection of the brain
- chronic renal failure
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg-Univerity
Mainz, 55131
About this study
Official title: 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.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- continuous veno-venous hemodialysis
- Keywords
- sepsis, cerebrovascular autoregulation, delirium
- Medical subject headings
- Sepsis, Shock, Septic, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous veno-venous hemodialysisProcedure or surgery
Also called Renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular autoregulation
Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock
Measured: during the first 4 days
Secondary outcomes (1)
Delirium
Incidence of Delirium at day 4 after severe sepsis or septic shock
Measured: at day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
- Investigators
- Patrick Schramm, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926301
- Sponsor's protocol ID
- 83743712
- Acronym
- SepsAR2
- Status last verified
- Jun 2020
- First submitted
- 17 Aug 2013
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01926301
- Acronym / sponsor ID
- SepsAR2 / 83743712
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- sepsis, cerebrovascular autoregulation, delirium
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | – | Procedure: continuous veno-venous hemodialysisPatients with severe sepsis or septic shock with acute renal failure and requirement of 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital
Key inclusion criteria (3 listed)
- severe sepsis or septic shock
- adult patients
- possibility of transcranial Doppler ultrasound
Key exclusion criteria (5 listed)
- traumatic brain injury
- known cerebrovascular diseases
- Infection of the brain
- chronic renal failure
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous veno-venous hemodialysisAlso: Renal replacement therapy | Procedure or surgery | Hemodialysis |
Primary outcome
Cerebrovascular autoregulation
Time frame: during the first 4 days
Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock
1 secondary outcome
Delirium
Time frame: at day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Schramm, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular autoregulation (time frame: during the first 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.