Working… Menu

Regional Cerebral Hemodynamics Related to Global Hemodynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Dorothea Closhen, Johannes Gutenberg University Mainz

Brief 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.

Condition or disease Intervention/treatment
Critically Ill Patients Other: PLR

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.

Layout table for study information
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

Intervention Details:
  • Other: PLR
    Other Name: To test fluid responsiveness passive leg raising is performed

Primary Outcome Measures :
  1. cerebral blood flow velocity [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Cerebral oxygen saturation [ Time Frame: 1 hour ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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
Study Population
critically ill patients mechanically ventilated patients

Inclusion Criteria:

  • critically ill
  • mechanically ventilated
  • needing advanced hemodynamic monitoring (PiCCO)

Exclusion Criteria:

  • <18years
  • > 80years
  • rhythm other than sinus

Information from the National Library of Medicine

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 identifier (NCT number): NCT01995565

Layout table for location information
Johannes Gutenberg University Mainz Recruiting
Mainz, Germany, 55131
Contact: Dorothea Closhen, MD    00496131170   
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         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Layout table for additonal information
Responsible Party: Dorothea Closhen, MD, Johannes Gutenberg University Mainz 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
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes