REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR) (RETROCAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Renal Transplant Recipient
• Intervention / Treatment: Other: standard of care

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive renal transplant récipients, apparied in a 1:2 ratio with non renal transplant récipients, undergoing cardiac surgery, and meeting the protocol criteria between january 2010 and december 2019, in university hospital of Bordeaux.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RENAL TRANSPLANT RECIPIENTS; All patients with previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass	Other: standard of care; retrospective study : standard of care
NON RENAL TRANSPLANT RECIPIENTS; All patients without previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass	Other: standard of care; retrospective study : standard of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate (GFR)	Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula	30 days after surgery
Glomerular Filtration Rate (GFR)	Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula	12 months after surgery
Vital status	Mortality after surgery	12 months after surgery
Major Adverse Kidney Events	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	Up to 12 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; acute kidney injury; renal function; renal transplant recipient; major adverse kidney events
• Other Study ID Numbers: SAR Sud study one

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No