Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Same-Day Hemodialysis
Procedure/SurgeryHemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure (typically in the morning prior to the procedure).
No Same-Day Hemodialysis
Procedure/SurgeryNo hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Same-Day HemodialysisExperimental treatment 1 intervention
Group B: No Same-Day HemodialysisActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room
Time frame
up to 1 day2
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 daySponsors and contacts
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Stanford University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov