NCT05788211

Brief Summary

This retrospective study assesses long term renal outcome in patients having suffered medical or post cardiotomy refractory cardiogenic shock requiring renal replacement therapy (RRT) concomitant with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The authors seek to establish for accurate definition of renal recovery status predicting poor long-term renal outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

February 24, 2023

Last Update Submit

May 15, 2024

Conditions

Cardiogenic ShockRenal Replacement TherapyVenoarterial Extracorporeal Membrane Oxygenation

Keywords

Cardiogenic shockRenal replacement therapyvenoarterial extracorporeal membrane oxygenationextra corporeal life supportmajor adverse kidney eventsacute kidney injuryend-stage renal diseaseserum creatinine

Outcome Measures

Primary Outcomes (3)

  • Complete renal recovery status according first definition

    decrease in serum creatinine level below 1.5 fold its basal value

    90 days from AKI (acute Kidney Injury) start

  • Complete renal recovery status according second definition

    decrease in serum creatinine level below 1.25 fold its basal value

    90 days from AKI start

  • Long term renal outcome

    proportion of patient meeting a composite criterion (overall mortality or dialysis dependency or doubling of basal serum creatinine)

    2 years from AKI start

Secondary Outcomes (8)

  • MAKE incidence

    7 days , 90 days, 1 year , 2 years from AKI start

  • MAKE incidence

    hospital discharge, an average of 60 days from AKI start

  • Renal recovery status

    7 days , 90 days, 1 year , 2 years from AKI start

  • Renal recovery status

    hospital discharge, an average of 60 days from AKI start

  • vital status

    1 year, 2 years from AKI start

  • +3 more secondary outcomes

Study Arms (1)

REFRACTORY CARDIOGENIC SHOCK

All patients with medical or postcardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation.

Other: standard of care

Interventions

standard of careOTHER

retrospective study: standard of care

REFRACTORY CARDIOGENIC SHOCK

Eligibility Criteria

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

Consecutive patients having suffered of medical or post cardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation, and meeting the protocol criteria between 2012, january the first and 2020, june the first.

You may qualify if:

  • Patients over 18 years old
  • Medical or post cardiotomy refractory cardiogenic shock
  • Patients requiring concomitant renal replacement therapy (RRT) and venoarterial extracorporeal membrane oxygenation (VA-ECMO)

You may not qualify if:

  • Congenital heart diseases
  • Severe pre operative chronic kidney disease (eGFR \< 30ml/min/1,73m2)
  • Death within the first 7 days of ECMO
  • Patient receiving non-concomitant ECMO and RRT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

Related Publications (2)

  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

    PMID: 15312219BACKGROUND

  • Pannu N, James M, Hemmelgarn B, Klarenbach S; Alberta Kidney Disease Network. Association between AKI, recovery of renal function, and long-term outcomes after hospital discharge. Clin J Am Soc Nephrol. 2013 Feb;8(2):194-202. doi: 10.2215/CJN.06480612. Epub 2012 Nov 2.

    PMID: 23124779BACKGROUND

MeSH Terms

Conditions

Shock, CardiogenicAcute Kidney InjuryKidney Failure, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of Cardiovascular Anesthesia and Critical care

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 28, 2023

Study Start

January 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

FR(1)