Acute Renal FailuredARICUCVVHNCT01376531
Influence Continuous Veno-venous Hemodialysis the Autoregulation
An observational study of Acute Renal Failure, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- continuous veno-venous hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jun 2011
- 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 at ICU with acute renal failure and the need of continuos veno-venous hemodialysis
Who may be able to join
- acute renal failure
- need for continuous veno-venous hemodialysis
- age >18 Years
Who cannot join
- Sepsis
- Preexisting cerebral illness
- traumatic brain injury
- Meningitis or encephalitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Continuous Veno-venous Hemodialysis on Cerebrovascular Autoregulation in Patients With Acute Renal Failure
The aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.
Read the detailed description
Patients at the intensive care unit who suffered acute renal failure with the need of continuous veno-venous hemodialysis will be investigated with continuous veno-venous hemodialysis and in a time window without continuous veno-venous hemodialysis to investigate the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.
- Conditions
- Acute Renal Failure
- Being tested
- continuous veno-venous hemodialysis
- Keywords
- acute renal failure, cerebrovascular autoregulation, transcranial Doppler, continuous veno-venous hemodialysis
- Medical subject headings
- Acute Kidney Injury
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 CVVHD
continuous veno-venous hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| acute renal failure | patients at intensive care unit with definition of acute renal failure and the need for continuous veno-venous hemodialysis Receives: Procedure: continuous veno-venous hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis
Is there an influence of continuous veno-venous hemodialysis at the cerebrovascular autoregulation, which would be a side effect with limiting use in patients with brain injury or the need of intensive monitoring of cerebral perfusion pressure in this patients.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 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, Department of Anesthesiology, University medicine Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376531
- Sponsor's protocol ID
- 837.041.10 2
- Acronym
- dARICUCVVH
- Status last verified
- Apr 2013
- First submitted
- 15 Jun 2011
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schramm P, Closhen D, Wojciechowski J, Berres M, Klein KU, Bodenstein M, Werner C, Engelhard K. Cerebrovascular autoregulation in critically ill patients during continuous hemodialysis. Can J Anaesth. 2013 Jun;60(6):564-9. doi: 10.1007/s12630-013-9912-z. Epub 2013 Mar 28.
PubMed 23536386
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Continuous Veno-venous Hemodialysis on Cerebrovascular Autoregulation in Patients With Acute Renal Failure
- ClinicalTrials.gov ID
- NCT01376531
- Acronym / sponsor ID
- dARICUCVVH / 837.041.10 2
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, cerebrovascular autoregulation, transcranial Doppler, continuous veno-venous hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jun 2011 (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 aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.
Detailed description
Patients at the intensive care unit who suffered acute renal failure with the need of continuous veno-venous hemodialysis will be investigated with continuous veno-venous hemodialysis and in a time window without continuous veno-venous hemodialysis to investigate the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute renal failure | – | Procedure: continuous veno-venous hemodialysispatients at intensive care unit with definition of acute renal failure and the need for 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 at ICU with acute renal failure and the need of continuos veno-venous hemodialysis
Key inclusion criteria (3 listed)
- acute renal failure
- need for continuous veno-venous hemodialysis
- age >18 Years
Key exclusion criteria (5 listed)
- Sepsis
- Preexisting cerebral illness
- traumatic brain injury
- Meningitis or encephalitis
- 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: CVVHDcontinuous veno-venous hemodialysis | Procedure or surgery | acute renal failure |
Primary outcome
Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis
Time frame: 1 Year
Is there an influence of continuous veno-venous hemodialysis at the cerebrovascular autoregulation, which would be a side effect with limiting use in patients with brain injury or the need of intensive monitoring of cerebral perfusion pressure in this patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Results publication: PubMed 23536386Schramm P, Closhen D, Wojciechowski J, Berres M, Klein KU, Bodenstein M, Werner C, Engelhard K. Cerebrovascular autoregulation in critically ill patients during continuous hemodialysis. Can J Anaesth. 2013 Jun;60(6):564-9. doi: 10.1007/s12630-013-9912-z. Epub 2013 Mar 28.
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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
Department of Anesthesiology, University medicine Mainz, Germany
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 Acute Renal Failure, 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: finished, as of the sponsor's last update on 15 Apr 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376531, which also lists 1 linked publication.
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 15 Apr 2013.