End Stage Kidney Disease (ESRD), Hemodialysis, Perioperative Management
Conditions
Brief 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.
Detailed description
Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.
Interventions
PROCEDURESame-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).
PROCEDURENo Same-Day Hemodialysis
No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.
Sponsors
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room | 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. | up to 1 day |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVikram Fielding-Singh, MD, JD
Stanford University
Outcome results
None listed