Regional Cerebral Hemodynamics Related to Global Hemodynamics

Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation

This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

Study Overview

• Status: Unknown
• Conditions: Critically Ill Patients
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Recruiting
    • Johannes Gutenberg University Mainz
    • Contact: Dorothea Closhen, MD; Phone Number: 00496131170; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

critically ill patients mechanically ventilated patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cerebral blood flow velocity	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Cerebral oxygen saturation	1 hour

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CLS_002; 837.437.11(7979) (Other Identifier: Ethics Commitee of Rhineland Palatinate)