End-Stage Renal Disease (ESRD) Clinical Trials

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Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the feasibility of two different preoperative hemodialysis schedules for people with end-stage kidney disease (ESKD) who undergo surgical procedures. The main questions it aims to answer are: Is it feasible to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Is it safe to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Researchers will compare the two hemodialysis schedules to see if the scheduling and safety profiles are the same. Participants will: Answer questions about their health up to 4 weeks before and 4 weeks after the surgical procedure. Receive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is willing to comply with all study procedures for the duration of the study

• Patient has a diagnosis of ESKD

• Patient initiated hemodialysis at least 90 days prior to the planned surgical procedure

• Patient is treated with a stable hemodialysis schedule, defined as an average of 2.5- 3.5 hemodialysis sessions per week in the preceding 4 weeks prior to surgery

• Patient is scheduled to undergo nonemergent surgical procedures in the Stanford Health Care system. This includes (but is not limited to):

‣ Fistula or graft creation, revision, or removal

⁃ Fistulogram

⁃ Peritoneal dialysis catheter placement or revision

⁃ Lower extremity angiogram (including femoral and iliac vessels)

⁃ Lower extremity bypass (including femoral and iliac vessels)

⁃ Lower extremity amputation

⁃ Lower extremity endarterectomy (including femoral and iliac vessels) Of note, this list of procedures is not exhaustive and other procedures may be considered that meet inclusion criteria and no exclusion criteria, in consultation with the treatment teams involved.

Locations
United States
California
Stanford University
RECRUITING
Stanford
Time Frame
Start Date: 2026-05-27
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 30
Treatments
Experimental: Same-Day Hemodialysis
Participants will receive same-day hemodialysis, defined as a hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure (typically in the morning prior to the procedure).
Active_comparator: No Same-Day Hemodialysis
Participants will not receive same-day hemodialysis, defined as a hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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