Regional Cerebral Hemodynamics Related to Global Hemodynamics

Critically Ill Patients Clinical Trial

Official title:

Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01995565
• Other study ID #: CLS_002
• Secondary ID: 837.437.11(7979)
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2013
• Last updated: November 25, 2013
• Start date: July 2011

Study information

• Verified date: July 2011
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• critically ill

• mechanically ventilated

• needing advanced hemodynamic monitoring (PiCCO)

Exclusion Criteria:

• <18years

• > 80years

• rhythm other than sinus

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

Other:
• PLR

Locations

Country	Name	City	State
Germany	Johannes Gutenberg University Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral blood flow velocity		1 hour	No
Secondary	Cerebral oxygen saturation		1 hour