NCT01122277

Brief Summary

The purpose of this observational study is the prospective documentation and evaluation of the status quo of volume therapy in German intensive care units.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

2 active sites

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

May 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 8, 2011

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

May 11, 2010

Last Update Submit

July 7, 2011

Conditions

Patients in ICU

Keywords

Volume therapyFluid therapyPatients in ICU

Eligibility Criteria

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

Patients in intensive care units with an indication for fluid/volume therapy

You may qualify if:

  • ICU patients with an indication for fluid/volume therapy

You may not qualify if:

  • Patients hospitalized by order of a court of law or a government agency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik für Anaesthesiologie, Klinikum der Universität München

Munich, Bavaria, 80336, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

  • Ertmer C, Zwissler B, Van Aken H, Christ M, Spohr F, Schneider A, Deisz R, Jacob M. Fluid therapy and outcome: a prospective observational study in 65 German intensive care units between 2010 and 2011. Ann Intensive Care. 2018 Feb 17;8(1):27. doi: 10.1186/s13613-018-0364-z.

    PMID: 29455308DERIVED

Study Officials

  • Matthias Jacob, MD

    Klinik für Anaesthesiologie, Klinikum der Universität München

    PRINCIPAL INVESTIGATOR

  • Christian Ertmer, MD

    Universitätsklinikum Münster, Germany

    PRINCIPAL INVESTIGATOR

  • Bernhard Zwissler, Prof

    Klinik für Anaesthesiologie, Klinikum der Universität München, Germany

    STUDY CHAIR

  • Hugo van Aken, Prof

    Universitätsklinikum Münster, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

October 1, 2011

Last Updated

July 8, 2011

Record last verified: 2010-10

Locations

DE(2)