NCT03423420

Brief Summary

Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,945

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

8 years

First QC Date

January 25, 2018

Last Update Submit

July 23, 2019

Conditions

Central Venous Pressure

Outcome Measures

Primary Outcomes (1)

  • mortality

    In-Hospital mortality

    an average of 30 days

Secondary Outcomes (13)

  • Central venous pressure

    intensive care unit stay, an average of 5 days

  • Hospital stay

    an average of 13 days

  • ICU stay

    an average of 5 days

  • ICU readmission

    an average of 30 days

  • Renal insufficiency - 1

    intensive care unit stay, an average of 5 days

  • +8 more secondary outcomes

Other Outcomes (5)

  • priority of surgery

    an average of 1 day

  • type of surgery

    an average of 1 day

  • duration

    an average of 4 hours

  • +2 more other outcomes

Eligibility Criteria

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

All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 patients.

You may qualify if:

  • In-patients of the Charité Universitätsmedizin Berlin
  • at least 18 years old
  • female or male sex
  • cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/13.
  • post-operative monitoring of anesthesiological intensive care unit

You may not qualify if:

  • previous cardiosurgical interventions during the same hospital stay.
  • incomplete documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Study Officials

  • Felix Balzer, MD, MSc, PhD

    Charite Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Dr. rer. nat., MSc

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 6, 2018

Study Start

January 1, 2006

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

DE(1)