Skip to main content
OpenTrials
Completed

NCT Number: NCT04979754

REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

In this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Post-operative mortality after cardiac surgery is increased in renal transplant recipients, compared with general population of cardiac surgery, or with kidney transplant recipients not undergoing cardiac surgery. If the survival of this specific population is now well studied, the long-term renal outcome is much less studied. Previous studies show a trend for increased risk of allograft dysfunction and need for permanent dialysis. This study proposes to compare long term renal outcome between renal transplant recipients and non-renal transplant recipients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Renal Transplant Recipients group:

  • Previous renal transplantation
  • Who underwent cardiac surgery with CPB

Inclusion criteria

for Non Renal Transplant Récipients group:

  • No previous renal transplantation
  • Who underwent cardiac surgery with CPB
  • Apparied with Renal Transplant récipients with the 5 following criteria : age, sex, previous diagnosis of diabete, type of cardiac surgery (isolated coronary artery bypass graft, valvular surgery, aorta surgery, combined surgery), best glomerular filtration rate with CKD-EPI formula at +/- 15 ml/min, in the 3 pre-operative months

Exclusion criteria

  • Patients requiring mechanical circulatory support (Extracorporeal Membrane Oxygenation)
  • Pre-operative permanent dialysis
  • Aorta dissection extended to renal arteries
  • Non-elective surgery for infective endocarditis
  • Previous hepatic, pancreatic or cardiac transplantation
  • Death in the 30 first days after cardiac surgery
  • Patient not meeting the inclusion criteria

Treatment and study plan

Standard of care

Other

retrospective study : standard of care

Primary outcomes

  1. Long-term renal outcome

    Time frame: 12 months after surgery

    Proportion of patients meeting a composite criterion : death or permanent dialysis or doubling the baseline serum creatinine value

Secondary outcomes

  1. Glomerular Filtration Rate (GFR)

    Time frame: 30 days after surgery

    Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula

  2. Glomerular Filtration Rate (GFR)

    Time frame: 12 months after surgery

    Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula

  3. Vital status

    Time frame: 12 months after surgery

    Mortality after surgery

  4. Major Adverse Kidney Events

    Time frame: Up to 12 months after surgery

    Major Adverse Kidney Events defined by new receipt of Renal replacement therapy (RRT), or Acute Kidney Injury (AKI) episodes with persistent renal dysfunction and final serum creatinine value before hospital discharge ≥ 200 % of the baseline serum creatinine

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Long-term Renal Outcome After Cardiac Surgery : Impact of Previous Renal Transplantation

Acronym: RETROCAR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.