NCT03209674

Brief Summary

The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2023

Enrollment Period

14 years

First QC Date

July 3, 2017

Last Update Submit

January 9, 2024

Conditions

Keywords

Cardiac surgeryThoracic surgery

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    death occurring in the same hospital where the operation took place before discharge from the hospital

    During follow-up, until discharge from hospital, up to 1 year.

Secondary Outcomes (6)

  • Postoperative shock

    In the first 24 hours after surgery

  • Length of stay in the ICU (days)

    During follow-up, until discharge from the ICU, up to 1 year.

  • Total length of stay (days)

    During follow-up, until discharge from the hospital, up to 1 year.

  • Mediastinitis

    During follow-up, until discharge from the hospital, up to 1 year.

  • Redo surgery

    During follow-up, until discharge from the hospital, up to 1 year.

  • +1 more secondary outcomes

Interventions

Cardiac or thoracic procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré

You may qualify if:

  • all patients eligible for cardiac or thoracic surgery

You may not qualify if:

  • non applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

RECRUITING

Related Publications (1)

  • Suc G, Estagnasie P, Brusset A, Procopi N, Squara P, Nguyen LS. Effect of BNP on risk assessment in cardiac surgery patients, in addition to EuroScore II. Sci Rep. 2020 Jul 2;10(1):10865. doi: 10.1038/s41598-020-67607-0.

MeSH Terms

Conditions

Heart DiseasesDeathPostoperative Complications

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Caroline Merand

    CMC Ambroise Paré

    STUDY CHAIR

Central Study Contacts

Alain Brusset, MD

CONTACT

Lee S Nguyen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

January 1, 2012

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 10, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

non-applicable.

Locations