REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

Completed

• Conditions: Cardiac Surgery; Renal Transplant Recipient; Cardiopulmonary Bypass
• Interventions: Other: standard of care

• Registration Number: NCT04979754
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-28
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NON RENAL TRANSPLANT RECIPIENTS	standard of care	All patients without previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass
RENAL TRANSPLANT RECIPIENTS	standard of care	All patients with previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Long-term renal outcome	12 months after surgery	Proportion of patients meeting a composite criterion : death or permanent dialysis or doubling the baseline serum creatinine value

Secondary Outcome Measures

Name	Time	Method
Vital status	12 months after surgery	Mortality after surgery
Glomerular Filtration Rate (GFR)	12 months after surgery	Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula
Major Adverse Kidney Events	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

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France