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Completed

NCT Number: NCT03379688

PDMS Outcome After Intensive Care, Organdysfunction and Monitoring

The objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure.

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Key information

Conditions

Pleural Effusion Blood Pressure Pleural Diseases Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10115, Germany

About this study

The close monitoring of patients after cardiac surgery is regarded as standard. However, little is currently known about the influence on patient-related outcome parameters. Recently it has already been shown that intraoperative variability of blood pressure during heart surgery has a postoperative effect on 30-day mortality.

The aim of this retrospective study is to investigate the effects of different hemodynamic measurements and management after cardiac surgery on patient-specific outcome parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Blood pressure in range

    Time frame: Intensive Care stay, an average of 10 days

    Percentage of RR (Blood Pressure) measurements taken by each patient in the target range as a percentage of the total number of measurements taken by that patient.

  2. Blood pressure over range

    Time frame: Intensive Care stay, an average of 10 days

    Percentage of RR measurements of each patient above the target range in relation to the total of all measurements taken by that patient.

  3. Blood pressure below range

    Time frame: Intensive Care stay, an average of 10 days

    Percentage of RR measurements taken by each patient below the target range in relation to the total number of measurements taken by that patient.

Secondary outcomes

  1. Hospital stay

    Time frame: an average of 13 days

    Length of hospital stay

  2. ICU stay

    Time frame: an average of 5 days

    Intensive care unit length of stay

  3. ICU readmission

    Time frame: an average of 30 days

    Amount of hospital readmissions

  4. Renal insufficiency - 1

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

    Incidence of renal insufficiency

  5. Renal insufficiency - 2

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

    dialysis duration

  6. Renal insufficiency - 3

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

    Urine production

  7. Stroke

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

    incidence of strokes

  8. Drainage loss

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

    Amount of postoperative drainage loss

  9. transfusions

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

    number of transfusions needed

  10. mortality rate-1

    Time frame: 90 days

    mortality rate after 90 days

  11. mortality rate-2

    Time frame: 180 days

    mortality rate after 180 days

  12. Pulse Contour Cardiac Output

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

    data received from Pulse Contour Cardiac Output analyses

  13. mortality rate-3

    Time frame: 5 years

    mortality rate after 5 years

  14. mortality rate-4

    Time frame: 1 year

    mortality rate after 1 year

  15. Central venous pressure

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

    central venous pressure on intensive care unit

  16. Pleural effusion

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

    In-hospital incidence of pleural effusions postoperatively

  17. Case cost

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

    Case cost in Euro

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Patient Data Management System Monitored Outcome After Intensive Care, Organdysfunction and Monitoring

Acronym: PONTOS

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Dec 20, 2017
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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