NIRS for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients

NCT06243900 | Enrolling By Invitation

• 1 other identifier: S2023-439-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-stage Renal Disease (ESRD)

Keywords

Hemodialysis; residual renal function; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (3)

• Change in the renal cerebral oxygen saturation

  Measured by Near Infrared Spectroscopy

  10 months

• time to anuria

  defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period

  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"

  10 months

Secondary Outcomes (7)

• serum creatinine

  10 months

• serum urea nitrogen

  10 months

• C-reactive protein (CRP)

  10 months

• Interleukin-6

  10 months

• TFF3

  10 months

Other Outcomes (3)

• hemoglobin

  10 months

• systolic pressure

  10 months

• diastolic pressure

  10 months

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

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuanjun Yang: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (20)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The peripheral blood samples are mainly used to detect creatinine, urea, hemoglobin, C-reactive protein (CRP), IL-6, etc. The urine samples are mainly used to detect kidney injury markers, such as TFF3, KIM-1, IP-10, etc.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyan Cai, PhD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 6, 2024
• Study Start: February 15, 2024
• Primary Completion: February 14, 2026
• Study Completion: February 14, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)