REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT04979754

Collaborator

(none)

Enrollment

Location

10.9

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Cardiopulmonary Bypass Renal Transplant Recipient	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 Design

Study Type:

Observational

Actual Enrollment :

93 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Glomerular Filtration Rate (GFR) [30 days after surgery]
Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula
Glomerular Filtration Rate (GFR) [12 months after surgery]
Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula
Vital status [12 months after surgery]
Mortality after surgery
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bordeaux University Hospital	Pessac		France	33604

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandre Ouattara, MD, PhD, University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT04979754

Other Study ID Numbers:

SAR Sud study one

First Posted:

Jul 28, 2021

Last Update Posted:

Dec 9, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexandre Ouattara, MD, PhD, University Hospital, Bordeaux

cardiac surgery

renal transplant recipient

renal function

acute kidney injury

major adverse kidney events

Study Results

No Results Posted as of Dec 9, 2021