- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07339202
Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial (POD-ESKD)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Satvik Sharma
- Phone Number: 650-736-9368
- Email: satviksh@stanford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
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).
|
|
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.
|
No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room
Time Frame: up to 1 day
|
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
|
up to 1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vikram Fielding-Singh, MD, JD, Stanford University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- 69235
- 5K23DK138312-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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