Regional Cerebral Hemodynamics Related to Global Hemodynamics
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ClinicalTrials.gov Identifier: NCT01995565 |
Recruitment Status : Unknown
Verified July 2011 by Dorothea Closhen, Johannes Gutenberg University Mainz.
Recruitment status was: Recruiting
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
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Condition or disease | Intervention/treatment |
---|---|
Critically Ill Patients | Other: PLR |
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 Type : | Observational |
Estimated Enrollment : | 64 participants |
Time Perspective: | Prospective |
Official Title: | Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | July 2014 |
- Other: PLR
Other Name: To test fluid responsiveness passive leg raising is performed
- cerebral blood flow velocity [ Time Frame: 1 hour ]
- Cerebral oxygen saturation [ Time Frame: 1 hour ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- critically ill
- mechanically ventilated
- needing advanced hemodynamic monitoring (PiCCO)
Exclusion Criteria:
- <18years
- > 80years
- rhythm other than sinus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995565
Germany | |
Johannes Gutenberg University Mainz | Recruiting |
Mainz, Germany, 55131 | |
Contact: Dorothea Closhen, MD 00496131170 closhen@uni-mainz.de | |
Principal Investigator: Dorothea Closhen, MD | |
Sub-Investigator: Guntehr Pestel, MD, PhD | |
Sub-Investigator: Matthias David, MD, PhD | |
Sub-Investigator: Kimiko Fukui, MD, PhD | |
Sub-Investigator: Patrick Schramm, MD | |
Sub-Investigator: Larissa Philippi, MD | |
Sub-Investigator: Lydia Strys, MD |
Responsible Party: | Dorothea Closhen, MD, Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT01995565 |
Other Study ID Numbers: |
CLS_002 837.437.11(7979) ( Other Identifier: Ethics Commitee of Rhineland Palatinate ) |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | November 26, 2013 |
Last Verified: | July 2011 |
Critical Illness Disease Attributes Pathologic Processes |