Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Stanford University
Stanford, California 94305
Contact:
Satvik Sharma
650-736-9368
satviksh@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.