PDMS Outcome After Intensive Care, Organdysfunction and Monitoring (PONTOS)

Patient Data Management System Monitored 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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Pleural Effusion

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 Type: Observational
• Enrollment (Actual): 6909

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • Charité Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac surgery patients; Patients undergoing cardiac surgery at Charité Campus Mitte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Felix Balzer, MD; PhD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: PONTOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No