Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06199609 |
| Other study ID # |
YXLL-KY-2023(130) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Qianfoshan Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is a retrospective cohort study aimed at evaluating the impact of autologous
arteriovenous fistula (AVF) on the heart, especially the left atrial structure, in patients
with end-stage renal disease (ESRD) through a retrospective cohort study. The aim is to
further clarify the relationship between the establishment of AVF and the occurrence of
atrial fibrillation, and provide a theoretical basis for exploring the relevant mechanisms of
AVF induced atrial fibrillation in the future.
Description:
1. Retrospective collection of ESRD patients who visited the Department of Nephrology at
the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital,
Shandong Province) from January 2014 to December 2022 for hemodialysis using AVF and
tunnel cuffed catheter (TCC) with a tunnel and polyester sheath. Follow up comparison of
the incidence of atrial fibrillation between the two groups;
2. Collect general clinical data (gender, age, primary disease, history, etc.),
echocardiography (atrioventricular diameter, wall thickness, left ventricular ejection
fraction, pulmonary artery pressure, etc.), and biochemical indicators (albumin, total
bilirubin, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen,
blood creatinine, blood calcium, blood phosphorus, hemoglobin, etc.) of AVF patients,
Analyze the changes in the structure of the heart, especially the left atrium, before
and after the establishment of AVF, and use binary logistic regression to analyze the
risk factors for new onset atrial fibrillation after AVF surgery;
3. According to whether new atrial fibrillation occurred after AVF surgery, patients were
divided into atrial fibrillation group and non atrial fibrillation group. The occurrence
of adverse clinical outcomes was followed up, and the Kaplan Meier survival curve was
used to analyze the impact of atrial fibrillation on patient adverse clinical outcomes.
Cox regression analysis was used to explore independent risk factors for adverse
clinical outcomes.
Follow up: Follow up will be conducted by a dedicated doctor from the establishment of AVF to
August 31, 2023. The main endpoint events are defined as all-cause death and cardiogenic
death, while the secondary endpoint events are readmission due to heart failure and stroke;
During the follow-up period, patients who underwent kidney transplantation, changed dialysis
methods, and did not experience endpoint events at the end of the follow-up were defined as
missing data.
