CClinicalTrials.gg
Status unknownNCT01995565Updated Nov 26, 2013

Regional Cerebral Hemodynamics Related to Global Hemodynamics

An observational study in Critically Ill Patients, sponsored by Johannes Gutenberg University Mainz. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by Johannes Gutenberg University Mainz · Observational

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Critically Ill Patients

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 64 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • \<18years
  • > 80years
  • rhythm other than sinus
05

Study design

Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Interventions

  • OtherPLR

    Also known as: To test fluid responsiveness passive leg raising is performed

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What researchers measure

Primary outcomes

  1. cerebral blood flow velocity

    Time frame: 1 hour

Secondary outcomes

  1. Cerebral oxygen saturation

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • Johannes Gutenberg University Mainz
    Mainz, 55131, Germany
    • Dorothea Closhen, MD · Contact · closhen@uni-mainz.de · 00496131170
    • Dorothea Closhen, MD · Principal 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 · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01995565
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Dorothea Closhen (MD, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Nov 26, 2013
Start date
Jul 2011
Primary completion
Jul 2014 (estimated)
Last update
Nov 26, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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