NIRS for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients (HDRRFI-NIRS)

February 5, 2024 updated by: Yuanjun Yang

NIRS: a Tool for the Diagnosis of Residual Renal Function Injury in Hemodialysis 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, 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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
  • Urine output > 500ml/day or GFR > 3ml/min/1.72m2;
  • Signed and dated informed consented is obtained.

Exclusion Criteria:

  • Presence of vascular access dysfunction (blood flow rate < 180ml/min);
  • COPD or blood oxygen saturation < 95%;
  • Severe heart failure;
  • Active infection;
  • Infectious disease;
  • Distance between the kidney and body surface > 4cm;
  • Severe pigmentation or skin lesions in the renal area;
  • Patients with severe anemia;
  • Patients with polycystic kidney disease;
  • Expected dialysis duration < 6 months;
  • Pregnancy or lactation women;
  • Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
  • Unwillingness to be followed up or poor adherence to treatment;
  • Other circumstances that the investigator considers unsuitable for enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the renal cerebral oxygen saturation
Time Frame: 10 months
Measured by Near Infrared Spectroscopy
10 months
time to anuria
Time Frame: 10 months
defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period
10 months
residual renal function (RRF)
Time Frame: 10 months
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"
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: 10 months
Taking a blood test to evaluation creatinine
10 months
serum urea nitrogen
Time Frame: 10 months
Taking a blood test to evaluation urea nitrogen
10 months
C-reactive protein (CRP)
Time Frame: 10 months
Taking a blood test to evaluation CRP
10 months
Interleukin-6
Time Frame: 10 months
Taking a blood test to evaluation Interleukin-6
10 months
TFF3
Time Frame: 10 months
Taking a urine test to evaluation TFF3
10 months
KIM-1
Time Frame: 10 months
Taking a urine test to evaluation KIM-1
10 months
IP-10
Time Frame: 10 months
Taking a urine test to evaluation IP-10
10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin
Time Frame: 10 months
Collect data at baseline and during each follow-up visit.
10 months
systolic pressure
Time Frame: 10 months
Collect data at baseline and during each follow-up visit.
10 months
diastolic pressure
Time Frame: 10 months
Collect data at baseline and during each follow-up visit.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuanjun Yang

Investigators

  • Study Director: Guangyan Cai, PhD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

February 14, 2026

Study Completion (Estimated)

February 14, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2023-439-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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