REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

NCT04979754 | Completed

• 1 other identifier: SAR Sud study one
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass; Renal Transplant Recipient

Keywords

cardiac surgery; renal transplant recipient; renal function; acute kidney injury; major adverse kidney events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Glomerular Filtration Rate (GFR)

  30 days after surgery

• Glomerular Filtration Rate (GFR)

  12 months after surgery

• Vital status

  12 months after surgery

• Major Adverse Kidney Events

  Up to 12 months after surgery

Study Arms (2)

RENAL TRANSPLANT RECIPIENTS

All patients with previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass

Other: standard of care

NON RENAL TRANSPLANT RECIPIENTS

All patients without previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass

Other: standard of care

Interventions

standard of care OTHER

retrospective study : standard of care

NON RENAL TRANSPLANT RECIPIENTS; RENAL TRANSPLANT RECIPIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Previous renal transplantation
• Who underwent cardiac surgery with CPB
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 28, 2021
• Study Start: November 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)