Regional Cerebral Hemodynamics Related to Global Hemodynamics

• ClinicalTrials.gov Identifier: NCT01995565
• Recruitment Status: Unknown
• First Posted: November 26, 2013
• Last Update Posted: November 26, 2013
• Sponsor: Johannes Gutenberg University Mainz
• Information provided by (Responsible Party): Dorothea Closhen, Johannes Gutenberg University Mainz

Study Description

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.

Study Design

• 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

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Cerebral oxygen saturation [ Time Frame: 1 hour ]

Eligibility Criteria

• 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Johannes Gutenberg University Mainz

More Information

• 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
• Last Update Posted: November 26, 2013
• Last Verified: July 2011

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes