NCT01995565

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

November 26, 2013

Status Verified

July 1, 2011

Enrollment Period

3 years

First QC Date

November 20, 2013

Last Update Submit

November 25, 2013

Conditions

Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

  • cerebral blood flow velocity

    1 hour

Secondary Outcomes (1)

  • Cerebral oxygen saturation

    1 hour

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

critically ill patients mechanically ventilated patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg University Mainz

Mainz, 55131, Germany

RECRUITING

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2014

Last Updated

November 26, 2013

Record last verified: 2011-07

Locations

DE(1)