PDMS Outcome After Intensive Care, Organdysfunction and Monitoring

Completed

• Conditions: Pleural Effusion; Blood Pressure

• Registration Number: NCT03379688
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2013-12-31
• Study Completion: 2014-07-01
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6909

Inclusion Criteria

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

Exclusion Criteria

1. previous cardiosurgical interventions during the same hospital stay.
2. incomplete documentation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure in range	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	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	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 Outcome Measures

Name	Time	Method
ICU stay	an average of 5 days	Intensive care unit length of stay
Renal insufficiency - 2	intensive care unit stay, an average of 5 days	dialysis duration
transfusions	hospital length of stay, an average of 13 days	number of transfusions needed
mortality rate-1	90 days	mortality rate after 90 days
Renal insufficiency - 1	intensive care unit stay, an average of 5 days	Incidence of renal insufficiency
mortality rate-2	180 days	mortality rate after 180 days
Pleural effusion	hospital length of stay, an average of 13 days	In-hospital incidence of pleural effusions postoperatively
Hospital stay	an average of 13 days	Length of hospital stay
mortality rate-4	1 year	mortality rate after 1 year
mortality rate-3	5 years	mortality rate after 5 years
Case cost	hospital length of stay, an average of 13 days	Case cost in Euro
ICU readmission	an average of 30 days	Amount of hospital readmissions
Renal insufficiency - 3	intensive care unit stay, an average of 5 days	Urine production
Drainage loss	intensive care unit stay, an average of 5 days	Amount of postoperative drainage loss
Pulse Contour Cardiac Output	intensive care unit stay, an average of 5 days	data received from Pulse Contour Cardiac Output analyses
Central venous pressure	intensive care unit stay, an average of 5 days	central venous pressure on intensive care unit
Stroke	hospital length of stay, an average of 13 days	incidence of strokes

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany