An observational study in End-stage Renal Disease (ESRD), sponsored by Yuanjun Yang. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Yuanjun Yang · Observational
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients, which not only affects the adequacy of dialysis and complications control but also impacts their quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury, and by the time it was discovered, the opportunity for effective treatment had been missed. The purpose of this study is to validate the value of near-infrared spectroscopy (NIRS) in the early diagnosis and prediction of residual renal injury. This will provide a basis for the application of NIRS in the early monitoring of residual renal injury in HD patients and offer a new method and perspective for the early diagnosis of residual renal injury in HD patients.
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients. Research has found that 25%-67% of HD patients progress to anuria within the first 10 months of starting dialysis. The rate of loss is much faster than peritoneal dialysis（PD）, and the more frequent the dialysis sessions, the faster the loss of RRF. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patient's quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury.
Traditionally, monitoring and diagnosing kidney damage have relied mainly on serum creatinine, urine output, and estimated glomerular filtration rate (eGFR). However, these indicators often occur after kidney damage has occurred, and their detection is delayed. The sensitivity for early diagnosis of kidney injury is low. By the time abnormalities are detected, the crucial treatment opportunity may have been missed. In addition, serum creatinine and other tests are susceptible to factors such as fluid dilution and reduced production in the body. Although some biomarkers for early diagnosis of acute kidney injury (AKI) have been developed domestically and internationally, most of them have not been applied in clinical practice and cannot be monitored in real-time. Moreover, these biomarkers may have significant differences in their generation between AKI and end-stage renal disease (ESRD) patients, making them unsuitable for early diagnosis and monitoring of residual renal injury in HD patients.
Near-infrared spectroscopy (NIRS) is a simple, safe, non-invasive, and real-time detection method that reflects organ perfusion by measuring changes in regional oxygen saturation. It is widely used in the diagnosis and prediction of neurological disorders, early prediction of AKI related to surgical procedures (cardiovascular, digestive, neurological, etc.), and monitoring of renal perfusion function after kidney transplantation. In theory, it can also be used for early diagnosis of residual renal injury in HD patients. This study is an exploratory research aiming to validate the value of NIRS in early diagnosis of residual renal injury by analyzing the correlation between renal oxygen saturation and urine output, as well as eGFR.
2,086 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 432 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Yuanjun Yang is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
Exclusion Criteria:
Change in the renal cerebral oxygen saturation
Measured by Near Infrared Spectroscopy
Time frame: 10 months
time to anuria
defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period
Time frame: 10 months
residual renal function (RRF)
The RRF was calculated from an interdialytic urine collection and pre- and post-dialysate blood samples as the mean of the urea and creatinine clearances adjusted for body surface area using a "GFR calculator"
Time frame: 10 months
serum creatinine
Taking a blood test to evaluation creatinine
Time frame: 10 months
serum urea nitrogen
Taking a blood test to evaluation urea nitrogen
Time frame: 10 months
C-reactive protein (CRP)
Taking a blood test to evaluation CRP
Time frame: 10 months
Interleukin-6
Taking a blood test to evaluation Interleukin-6
Time frame: 10 months
TFF3
Taking a urine test to evaluation TFF3
Time frame: 10 months
KIM-1
Taking a urine test to evaluation KIM-1
Time frame: 10 months
IP-10
Taking a urine test to evaluation IP-10
Time frame: 10 months
hemoglobin
Collect data at baseline and during each follow-up visit.
Time frame: 10 months
systolic pressure
Collect data at baseline and during each follow-up visit.
Time frame: 10 months
diastolic pressure
Collect data at baseline and during each follow-up visit.
Time frame: 10 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Yuanjun Yang