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Recruiting NCT07339202

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

No phase Interventional Perioperative Management End Stage Kidney Disease (ESRD) Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Same-Day Hemodialysis, No Same-Day Hemodialysis.
Who it may be relevant to
Registry conditions: Perioperative Management, End Stage Kidney Disease (ESRD), Hemodialysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.

Interventions

  • Procedure Same-Day Hemodialysis
    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).
  • Procedure No Same-Day Hemodialysis
    No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.

Primary outcome measures

  • Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room [Time frame: up to 1 day]
  • Number of participants who experience electrolyte abnormalities or volume overload requiring additional unplanned hemodialysis, rescheduling / cancellation of the surgical procedure, or an unanticipated escalation of postoperative level of care. [Time frame: up to 1 day]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patient is pregnant
  • Patient is a prisoner
  • Patient is < 18 years old
  • The treating clinicians determine that the patient's clinical condition necessitate a specific approach to surgical scheduling or preoperative hemodialysis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Publications

  • Fielding-Singh V, Vanneman MW, Grogan T, Neelankavil JP, Winkelmayer WC, Chang TI, Liu VX, Lin E. Association Between Preoperative Hemodialysis Timing and Postoperative Mortality in Patients With End-stage Kidney Disease. JAMA. 2022 Nov 8;328(18):1837-1848. doi: 10.1001/jama.2022.19626. PMID 36326747
  • Fielding-Singh V, Vanneman MW, Morris AM, Winkelmayer WC, Sun LY, Roshanov PS, Montez-Rath ME, Chertow GM, Lin E. Preoperative Dialysis Dose and Postoperative Outcomes in Patients Receiving Maintenance Hemodialysis. Kidney360. 2025 Nov 1;6(11):1948-1959. doi: 10.34067/KID.0000000874. Epub 2025 Jun 12. PMID 40504620

Identifiers

NCT: NCT07339202 · 69235 · 5K23DK138312-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗