REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

Cardiac Surgery Clinical Trial

— RETROCAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979754
• Other study ID #: SAR Sud study one
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Renal Transplant Recipient

Intervention

Other:
• standard of care
retrospective study : standard of care

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glomerular Filtration Rate (GFR)	Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula	30 days after surgery
Secondary	Glomerular Filtration Rate (GFR)	Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula	12 months after surgery
Secondary	Vital status	Mortality after surgery	12 months after surgery
Secondary	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