Pontos-Central Venous Pressure and Cardiac Surgery | NCT03423420

Studies
Pontos-Central Venous Pressure and Cardiac Surgery

NCT03423420

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 25, 2019Actual

Enrollment

5,945Actual

Phase

Not provided

Conditions

Central Venous Pressure

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2006Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Dec 31, 2013Actual

First Submitted Date

Jan 25, 2018

First Submission Date that Met QC Criteria

Feb 2, 2018

First Posted Date

Feb 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felix Balzer, Prof. Dr. med. Dr. rer. nat., MSc, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,945Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	In-Hospital mortality	an average of 30 days

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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 12/13.
post-operative monitoring of anesthesiological intensive care unit

Exclusion Criteria:

previous cardiosurgical interventions during the same hospital stay.
incomplete documentation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felix Balzer, MD, MSc, PhD	Charite Universitätsmedizin Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitaetsmedizin Berlin		Berlin		10117	Germany