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

Stanford University

Status: Not yet enrolling

Conditions: Hemodialysis; Perioperative Management; End Stage Kidney Disease (ESRD)

Treatments: Procedure: Same-Day Hemodialysis; Procedure: No Same-Day Hemodialysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07339202

69235

5K23DK138312-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

2. Patient has a diagnosis of ESKD

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

4. 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

5. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Same-Day Hemodialysis

Experimental group

Description:

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).

Treatment:

Procedure: Same-Day Hemodialysis

No Same-Day Hemodialysis

Active Comparator group

Description:

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.

Treatment:

Procedure: No Same-Day Hemodialysis