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Clinical Trials/NCT03379688
NCT03379688
Completed
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country6,909 target enrollmentJanuary 1, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pleural Effusion
Sponsor
Charite University, Berlin, Germany
Enrollment
6909
Locations
1
Primary Endpoint
Blood pressure in range
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2006
End Date
July 1, 2014
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Felix Balzer

PD Dr. med. Dr. rer. nat., MSC

Charite University, Berlin, Germany

Eligibility Criteria

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/
  • post-operative monitoring of anesthesiological intensive care unit

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

  • Drainage loss(intensive care unit stay, an average of 5 days)
  • ICU stay(an average of 5 days)
  • Renal insufficiency - 2(intensive care unit stay, an average of 5 days)
  • transfusions(hospital length of stay, an average of 13 days)
  • mortality rate-1(90 days)
  • Renal insufficiency - 1(intensive care unit stay, an average of 5 days)
  • mortality rate-2(180 days)
  • Pleural effusion(hospital length of stay, an average of 13 days)
  • Hospital stay(an average of 13 days)
  • Stroke(hospital length of stay, an average of 13 days)
  • mortality rate-4(1 year)
  • Case cost(hospital length of stay, an average of 13 days)
  • mortality rate-3(5 years)
  • ICU readmission(an average of 30 days)
  • Renal insufficiency - 3(intensive care unit stay, an average of 5 days)
  • Pulse Contour Cardiac Output(intensive care unit stay, an average of 5 days)
  • Central venous pressure(intensive care unit stay, an average of 5 days)

Study Sites (1)

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