Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss

NCT07003828 | Active Not Recruiting

• 1 other identifier: S2024-294-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. The aim of this study was to characterize the changes in renal perfusion in incident HD patients with preserved RRF during dialysis sessions and to provide new strategies for RRF preservation.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Keywords

hemodialysis

Outcome Measures

Primary Outcomes (1)

• Renal perfusion

  Renal perfusion was quantified using the CEUS-assessed perfusion index (PI). The primary outcome measure was the PI.

  at three time points during the HD session: pre-dialysis baseline, intradialytic phase (3 hours post-initiation)

Study Arms (1)

adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD

Diagnostic Test: CEUS examinations

Interventions

CEUS examinations DIAGNOSTIC_TEST

CEUS examinations were performed at three predetermined time points during each HD session: immediately before, 3 hours after HD initiation, and 15 minutes post-dialysis.

adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD

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

A total of thirty patients from the First Medical Center of Chinese PLA General Hospital were consecutively enrolled in the study (as detailed in the Study Design section) after providing written informed consent.

You may qualify if:

• (1) adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD; (2) preserved RRF defined as urinary output \>500 mL/24 h or eGFR ≥3 mL/min/1.73 m²

You may not qualify if:

• (1) known allergy to sulfur hexafluoride microbubbles (SonoVue®) microbubbles; (2) vascular access dysfunction; (3) combined peritoneal dialysis; (4)severe cardiopulmonary disease; (5) active infection or malignancy; (6) communicable diseases; (7) pregnancy or breastfeeding; (8) participation in other clinical trials.

Sponsors & Collaborators

• Yuanjun Yang: lead

Study Sites (1)

the First Medical Center of Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (1)

• Xie D, Tan J, Zhang Q, Yu Q, Wang Y, Wang Y, Gao L, Yan L, Zhou J, Li N, Cai G. Hemodialysis-induced renal perfusion decline: unraveling the pathophysiological mechanisms linking intradialytic circulatory stress to residual renal function loss. Front Pharmacol. 2025 Oct 20;16:1648608. doi: 10.3389/fphar.2025.1648608. eCollection 2025.

  PMID: 41190031 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)