Hemodialysis Timing for Kidney Failure

(POD-ESKD Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the optimal timing for hemodialysis, a treatment that filters waste from the blood, in individuals with end-stage kidney disease (ESKD) undergoing non-urgent surgeries. Researchers aim to determine whether having dialysis on the same day as surgery is safe and feasible compared to not having it that day. Participants will either receive same-day hemodialysis on the morning of their surgery or no same-day hemodialysis, depending on their study group. Ideal candidates are those with ESKD who have maintained a steady dialysis schedule for at least 90 days and are planning a non-emergency surgery at Stanford Health Care. As an unphased trial, this study allows participants to contribute to significant research that could enhance surgical outcomes for future patients with ESKD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these hemodialysis schedules are safe for surgical patients with ESKD?

Research shows that hemodialysis is generally well-tolerated by people with end-stage kidney disease (ESKD). Studies have found that regular dialysis helps manage uremia, a condition where waste builds up in the blood, and reduces the frequency of low blood pressure episodes during treatment. However, many people on dialysis also face other health issues like diabetes or heart problems, which can affect their treatment experience.

Reports indicate that ESKD is a serious condition often leading to additional health problems, but hemodialysis remains a common and well-established treatment. Despite some risks, it is considered safe enough to be a standard procedure for those with kidney failure. Participants in this trial receiving same-day hemodialysis will be closely monitored to ensure the treatment's safety and effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of hemodialysis for patients with kidney failure undergoing surgery. Unlike the traditional approach of scheduling hemodialysis a day or more before surgery, this trial examines the effects of same-day hemodialysis. The unique feature of this method is its potential to optimize patient outcomes by providing dialysis treatment closer to the surgical procedure. By investigating whether this timing can reduce complications and improve recovery, the trial could lead to more effective management strategies for patients with kidney failure.

What evidence suggests that these hemodialysis schedules are effective for end-stage kidney disease?

Research suggests that undergoing hemodialysis on the same day as surgery might affect patient recovery. Studies have found that longer hemodialysis sessions reduce the risk of death by 33% compared to shorter sessions. Additionally, hemodiafiltration, a similar treatment, can improve outcomes for patients with severe kidney disease by lowering the risk of death. However, little information exists on how same-day hemodialysis impacts surgery results. This trial will compare two approaches: some participants will receive same-day hemodialysis, while others will not, to determine whether this timing makes a difference.678910

Who Is on the Research Team?

VF

Vikram Fielding-Singh, MD, JD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for people with end-stage kidney disease (ESKD) who have been on a stable hemodialysis schedule for at least 90 days before their non-emergency surgery. They must be willing to follow the study's procedures and can't participate if they don't meet these requirements.

Inclusion Criteria

I have had a bypass surgery in my leg.
I have had an amputation below the hip.
I started hemodialysis more than 90 days before my scheduled surgery.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants answer questions about their health up to 4 weeks before the surgical procedure

4 weeks

Treatment

Participants receive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of 30-day postoperative outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • No Same-Day Hemodialysis
  • Same-Day Hemodialysis

Trial Overview

The POD-ESKD Pilot Trial is testing whether it's feasible and safe to perform hemodialysis on the same day as surgery compared to not doing so. Participants will either receive hemodialysis on the day of their surgical procedure or they won't, based on random assignment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Same-Day HemodialysisExperimental Treatment1 Intervention
Group II: No Same-Day HemodialysisActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Patient-focused outcomes after initiation of dialysis for ESRD

One-year mortality for ESRD patients initiating dialysis was 33.8%. Functional impairment occurred in 27.1% of patients, while 82.8% of patients required ...

Effect of Hemodiafiltration or Hemodialysis on Mortality in ...

In our trial, we found a lower risk of death from any cause among patients with kidney failure who were receiving high-dose hemodiafiltration than among those ...

Epidemiology of haemodialysis outcomes

According to US Renal Data System (USRDS) data, approximately 10% of patients receiving HD died within 30 days of discharge. The SONG-HD ...

Extended-hours hemodialysis is associated with lower ...

Patients treated with extended-hours hemodialysis had a 33% lower adjusted risk of death compared to those who were treated with a conventional regimen.

Effect of hemodiafiltration and hemodialysis on mortality ...

This meta-analysis suggests that hemodiafiltration leads to better outcomes for patients with end-stage renal disease, particularly a reduction ...

Epidemiology of haemodialysis outcomes - PMC

Data for Canada exclude Quebec. Data for Italy are representative of 38% of patients with kidney failure. Japan data include only patients receiving dialysis.

Patient-focused outcomes after initiation of dialysis for ESRD

The majority of comorbidities including diabetes mellitus and congestive heart failure were more frequent in dialysis patients than in the reference population ...

Daily Hemodialysis and the Outcome of Acute Renal Failure

Daily hemodialysis resulted in better control of uremia, fewer hypotensive episodes during hemodialysis, and more rapid resolution of acute renal failure.

Reported Cases of End-Stage Kidney Disease

End-stage kidney disease (ESKD) (kidney failure requiring dialysis or transplantation) is a disabling condition that often results in premature ...

Outcomes of end‐stage renal disease patients in ...

US renal data system 2018 annual data report: epidemiology of kidney disease ... patients with sepsis, heart failure, end‐stage renal disease, and cirrhosis.