Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room
研究概览
简要总结
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.
详细描述
Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •, 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
研究组 & 干预措施
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).
干预措施: Same-Day Hemodialysis (Procedure)
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.
干预措施: No Same-Day Hemodialysis (Procedure)
结局指标
主要结局
Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room
时间窗: 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.
时间窗: up to 1 day
次要结局
未报告次要终点
研究者
Vikram Fielding-Singh
Clinical Associate Professor, Department of Anesthesiology
Stanford University