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CompletedNCT03423420Updated Jul 25, 2019

Pontos-Central Venous Pressure and Cardiac Surgery

An observational study in Central Venous Pressure, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,945
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Central Venous Pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • previous cardiosurgical interventions during the same hospital stay.
  • incomplete documentation
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,945 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. mortality

    In-Hospital mortality

    Time frame: an average of 30 days

Secondary outcomes

  1. Central venous pressure

    central venous pressure on intensive care unit

    Time frame: intensive care unit stay, an average of 5 days

  2. Hospital stay

    Length of hospital stay

    Time frame: an average of 13 days

  3. ICU stay

    Intensive care unit length of stay

    Time frame: an average of 5 days

  4. ICU readmission

    Amount of hospital readmissions

    Time frame: an average of 30 days

  5. Renal insufficiency - 1

    Incidence of renal insufficiency

    Time frame: intensive care unit stay, an average of 5 days

  6. Renal insufficiency - 2

    dialysis duration

    Time frame: intensive care unit stay, an average of 5 days

  7. Renal insufficiency - 3

    Urine production

    Time frame: intensive care unit stay, an average of 5 days

  8. Stroke

    incidence of strokes

    Time frame: hospital length of stay, an average of 13 days

  9. mortality rate-1

    mortality rate after 90 days

    Time frame: 90 days

  10. mortality rate-2

    mortality rate after 180 days

    Time frame: 180 days

  11. mortality rate-3

    mortality rate after 3 years

    Time frame: 3 years

  12. mortality rate-4

    mortality rate after 1 year

    Time frame: 1 year

  13. mortality rate-5

    mortality rate after 5 years

    Time frame: 5 years

Other outcomes

  1. priority of surgery

    priority of surgery selected from a three point categorial scale with the categories elective, urgent and emergency

    Time frame: an average of 1 day

  2. type of surgery

    type of surgery selected from the three point categorial scale with categories bypass graft, valve replacement or combination of both

    Time frame: an average of 1 day

  3. duration

    duration of surgery

    Time frame: an average of 4 hours

  4. APACHE II

    APACHE II Score of patients on admission on the ICU

    Time frame: an average of 30 days

  5. ACEF Score

    preoperative ACEF Score of patients undergoing surgery

    Time frame: an average of 1 day

06

Study locations

1 site
  • Charité - Universitaetsmedizin Berlin
    Berlin, 10117, Germany
07

Registry details

Key details

Study ID
NCT03423420
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Felix Balzer (Prof. Dr. med. Dr. rer. nat., MSc, Charite University, Berlin, Germany) — Principal investigator
First posted
Feb 6, 2018
Start date
Jan 1, 2006
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013
Last update
Jul 25, 2019

Study contacts

Felix Balzer, MD, MSc, PhD
principal investigator · Charite Universitätsmedizin Berlin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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