PDMS Outcome After Intensive Care, Organdysfunction and Monitoring

Blood Pressure Clinical Trial

— PONTOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379688
• Other study ID #: PONTOS
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: July 1, 2014

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6909
• Est. completion date: July 1, 2014
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Pleural Effusion

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Aronson S, Dyke CM, Levy JH, Cheung AT, Lumb PD, Avery EG, Hu MY, Newman MF. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011 Jul;113(1):19-30. doi: 10.1213/ANE.0b013e31820f9231. Epub 2011 Feb 23. — View Citation

Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9. — View Citation

Carl M, Alms A, Braun J, Dongas A, Erb J, Goetz A, Goepfert M, Gogarten W, Grosse J, Heller AR, Heringlake M, Kastrup M, Kroener A, Loer SA, Marggraf G, Markewitz A, Reuter D, Schmitt DV, Schirmer U, Wiesenack C, Zwissler B, Spies C. S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system. Ger Med Sci. 2010 Jun 15;8:Doc12. doi: 10.3205/000101. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure in range	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.	Intensive Care stay, an average of 10 days
Primary	Blood pressure over range	Percentage of RR measurements of each patient above the target range in relation to the total of all measurements taken by that patient.	Intensive Care stay, an average of 10 days
Primary	Blood pressure below range	Percentage of RR measurements taken by each patient below the target range in relation to the total number of measurements taken by that patient.	Intensive Care stay, an average of 10 days
Secondary	Hospital stay	Length of hospital stay	an average of 13 days
Secondary	ICU stay	Intensive care unit length of stay	an average of 5 days
Secondary	ICU readmission	Amount of hospital readmissions	an average of 30 days
Secondary	Renal insufficiency - 1	Incidence of renal insufficiency	intensive care unit stay, an average of 5 days
Secondary	Renal insufficiency - 2	dialysis duration	intensive care unit stay, an average of 5 days
Secondary	Renal insufficiency - 3	Urine production	intensive care unit stay, an average of 5 days
Secondary	Stroke	incidence of strokes	hospital length of stay, an average of 13 days
Secondary	Drainage loss	Amount of postoperative drainage loss	intensive care unit stay, an average of 5 days
Secondary	transfusions	number of transfusions needed	hospital length of stay, an average of 13 days
Secondary	mortality rate-1	mortality rate after 90 days	90 days
Secondary	mortality rate-2	mortality rate after 180 days	180 days
Secondary	Pulse Contour Cardiac Output	data received from Pulse Contour Cardiac Output analyses	intensive care unit stay, an average of 5 days
Secondary	mortality rate-3	mortality rate after 5 years	5 years
Secondary	mortality rate-4	mortality rate after 1 year	1 year
Secondary	Central venous pressure	central venous pressure on intensive care unit	intensive care unit stay, an average of 5 days
Secondary	Pleural effusion	In-hospital incidence of pleural effusions postoperatively	hospital length of stay, an average of 13 days
Secondary	Case cost	Case cost in Euro	hospital length of stay, an average of 13 days