Pontos-Central Venous Pressure and Cardiac Surgery

High Central Venous Pressure After Cardiac Surgery is Associated With Increased Morbidity and Mortality

Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Central Venous Pressure

• Study Type: Observational
• Enrollment (Actual): 5945

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	In-Hospital mortality	an average of 30 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-3	mortality rate after 3 years	3 years
mortality rate-4	mortality rate after 1 year	1 year
mortality rate-5	mortality rate after 5 years	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
priority of surgery	priority of surgery selected from a three point categorial scale with the categories elective, urgent and emergency	an average of 1 day
type of surgery	type of surgery selected from the three point categorial scale with categories bypass graft, valve replacement or combination of both	an average of 1 day
duration	duration of surgery	an average of 4 hours
APACHE II	APACHE II Score of patients on admission on the ICU	an average of 30 days
ACEF Score	preoperative ACEF Score of patients undergoing surgery	an average of 1 day

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Felix Balzer, MD, MSc, PhD, Charité Universitätsmedizin Berlin

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PONTOS-CVP

Drug and device information, study documents

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