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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK138312-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | 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 |
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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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikram Fielding-Singh, MD, JD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36326747 | Background | 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. | |
| 40504620 | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| No Same-Day Hemodialysis | Procedure | No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure. |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |