Critically Ill PatientsNCT01995565
Regional Cerebral Hemodynamics Related to Global Hemodynamics
An observational study of Critically Ill Patients, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- PLR
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jul 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients mechanically ventilated patients
Who may be able to join
- critically ill
- mechanically ventilated
- needing advanced hemodynamic monitoring (PiCCO)
Who cannot join
- <18years
- > 80years
- rhythm other than sinus
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johannes Gutenberg University Mainz
Mainz, 55131
Dorothea Closhen, MD, 00496131170, closhen@uni-mainz.de
Dorothea Closhen, MD
About this study
Official title: Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation
This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.
Read the detailed description
Cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. Noninvasive monitoring techniques are established. When detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided.
In critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. Systemic hemodynamic changes can be monitored using PiCCO® system (pulse contour cardiac output, Pulsion Medical Systems, Munich, Germany) that combines transpulmonal thermodilution and pulse contour analysis. PiCCO® continuously monitors cardiac output (CO), as well as static parameters like global enddiastolic blood volume index (GEDVI), and dynamic parameters as difference in pulse pressure (dPP) and stroke volume variation (SVV), respectively. CC Nexfin® (BMeye, Amsterdam, The Netherlands) is a noninvasive hemodynamic monitor.
This study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.
- Conditions
- Critically Ill Patients
- Being tested
- PLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLROther
Also called To test fluid responsiveness passive leg raising is performed
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral blood flow velocity
Measured: 1 hour
Secondary outcomes (1)
Cerebral oxygen saturation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothea Closhen, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995565
- Sponsor's protocol ID
- CLS_002
- Other IDs
- 837.437.11(7979)
- Status last verified
- Jul 2011
- First submitted
- 20 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation
- ClinicalTrials.gov ID
- NCT01995565
- Acronym / sponsor ID
- CLS_002
- Conditions
- Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- First posted
- 26 Nov 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.
This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.
Detailed description
Cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. Noninvasive monitoring techniques are established. When detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided.
In critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. Systemic hemodynamic changes can be monitored using PiCCO® system (pulse contour cardiac output, Pulsion Medical Systems, Munich, Germany) that combines transpulmonal thermodilution and pulse contour analysis. PiCCO® continuously monitors cardiac output (CO), as well as static parameters like global enddiastolic blood volume index (GEDVI), and dynamic parameters as difference in pulse pressure (dPP) and stroke volume variation (SVV), respectively. CC Nexfin® (BMeye, Amsterdam, The Netherlands) is a noninvasive hemodynamic monitor.
This study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients mechanically ventilated patients
Key inclusion criteria (3 listed)
- critically ill
- mechanically ventilated
- needing advanced hemodynamic monitoring (PiCCO)
Key exclusion criteria (3 listed)
- <18years
- > 80years
- rhythm other than sinus
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 |
|---|---|---|
| PLRAlso: To test fluid responsiveness passive leg raising is performed | Other | – |
Primary outcome
cerebral blood flow velocity
Time frame: 1 hour
1 secondary outcome
Cerebral oxygen saturation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
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 Critically Ill Patients, 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 3 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: status not confirmed, as of the sponsor's last update on 26 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral blood flow velocity (time frame: 1 hour). 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 26 Nov 2013.