Regional Cerebral Hemodynamics Related to Global Hemodynamics

• Conditions: Critically Ill Patients

• Registration Number: NCT01995565
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-25
• Last Update Submitted: 2013-11-25
• Study First Posted: 2013-11-26
• Last Update Posted: 2013-11-26
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cerebral blood flow velocity	1 hour

Secondary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation	1 hour

Trial Locations

Locations (1)

Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Germany