NCT04082312

Brief Summary

Post-cardiotomy cardiogenic shock (PCCS) occurs in 2-6% of patients undergoing cardiac surgery, and 1% of cardiac surgery patients will require mechanical circulatory support using Veno-Arterial ExtraCorporeal Membrane Oxygenation (VA-ECMO). Acute Kidney Injury is a frequent complication in this population and negatively impacts the survival. We aimed to determine whether the timing of ECMO implantation influence the renal prognosis of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 5, 2019

Last Update Submit

September 11, 2023

Conditions

Keywords

Acute Kidney InjuryECMOPost Cardiogenic Shock Syndrome

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a stage 3 AKI

    Number of Participants with Stage 3 Acute Kidney Injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) group

    Day 10 after ECMO implantation

Secondary Outcomes (2)

  • Mortality at Day 30

    Day 30 after ECMO implantation

  • Mortality at 6 months

    6 months after ECMO implantation

Study Arms (3)

Group 1

Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + with KDIGO stage 3 AKI

Other: No intervention

Group 2

Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + without KDIGO stage 3 AKI and alive at D10

Other: No intervention

Group 3

Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + died before D10 without KDIGO stage 3 AKI

Other: No intervention

Interventions

No intervention

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted in the Surgical Intensive Care Unit of the Cardiology Institute of La Pitié Salpêtrière University Hospital (Paris, France) between January 2013 and December 2016.

You may qualify if:

  • All patients admitted in post-operative of cardiac surgery
  • Assisted by VA-ECMO

You may not qualify if:

  • Chronic hemodialysis
  • Death occurring within the first 48 hours of VA-ECMO implantation
  • Multiple VA-ECMO during the same hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Adrien Bouglé

Paris, 75013, France

Location

Related Publications (1)

  • Lepere V, Duceau B, Lebreton G, Bombled C, Dujardin O, Boccara L, Charfeddine A, Amour J, Hajage D, Bougle A. Risk Factors for Developing Severe Acute Kidney Injury in Adult Patients With Refractory Postcardiotomy Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Crit Care Med. 2020 Aug;48(8):e715-e721. doi: 10.1097/CCM.0000000000004433.

MeSH Terms

Conditions

Acute Kidney InjuryShock, Cardiogenic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgical Intensive Care Unit

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

May 1, 2016

Primary Completion

May 5, 2019

Study Completion

July 5, 2019

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations