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

NCT07339202 | Not Yet Recruiting

• 2 other identifiers: 692355K23DK138312-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Same-Day Hemodialysis

EXPERIMENTAL

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

No Same-Day Hemodialysis

ACTIVE COMPARATOR

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

Interventions

Same-Day Hemodialysis 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).

Same-Day Hemodialysis

No Same-Day Hemodialysis PROCEDURE

No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.

No Same-Day Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 36326747 BACKGROUND

• 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.

  PMID: 40504620 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vikram Fielding-Singh, MD, JD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 14, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)