Extra Ultrafiltration to Remove Fluid in Hemodialysis Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study enrolls adults with end stage kidney disease who are already receiving thrice-weekly in-center hemodialysis and show signs of volume overload. Participants are randomized to four weeks of extra ultrafiltration, eight weeks of extra ultrafiltration, or continuation of standard dialysis without additional ultrafiltration. Each ultrafiltration arm adds two extra four-hour sessions per week and includes pharmacist-guided adjustments to blood pressure medications. Primary outcomes examine changes in 24-hour blood pressure and congestion-related symptoms from baseline to 24 weeks, with secondary measures of related symptoms, physical activity, hemodynamics, and safety. The study is sponsored by the University of Washington with NIDDK collaboration and is conducted at Northwest Kidney Centers in Seattle.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:

  1. Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.

     OR
  2. Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score \<75.

     Exclusion Criteria:
* Age \<18 years
* Receiving hemodialysis treatments for acute kidney injury
* Receiving hemodialysis treatments for less than four weeks
* Planned switch to peritoneal or home dialysis within next three months
* Current or planned incremental hemodialysis (less than 3 treatments per week)
* Current or planned intensive hemodialysis (four or more treatments per week)
* Scheduled kidney transplantation
* Major cardiovascular or bleeding event within previous 90 days
* Receiving chemotherapy or radiation treatment for cancer
* History of cirrhosis with ascites
* Inability to complete 24-hour ambulatory blood pressure measurement
* Wheelchair dependance or other inability to complete six-minute walk test
* Pre-dialysis systolic blood pressure \<100 mmHg
* Scheduled use of midodrine with hemodialysis treatments
* History of non-adherence with dialysis treatments
* Pregnancy
* Institutionalized
* Current or pending enrollment in hospice care
* Inappropriate for enrollment based on investigator or nephrologist discretion

Where it's running

• Northwest Kidney Centers
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Bryan Kestenbaum, MD, MS — University of Washington
• Study coordinator: Luisa Rios-Avila
• Email: lrios1@uw.edu
• Phone: 206-258-9325

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)

  This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.

  Recruiting Vivalyx GmbH · Rotterdam · NCT07792317

• Remote monitoring in dialysis: comparing RPM-APD, manual PD, and maintenance HD

  This study tests how well three dialysis approaches work for adults with ESRD starting dialysis in China, using real-world data from routine care.

  Recruiting Vantive Health LLC · Beijing, Beijing Municipality and 19 other locations · NCT07781124

• Calciphylaxis in people with chronic kidney disease: causes, risks, and early signs

  This project will compare adults with chronic kidney disease who develop calciphylaxis to matched CKD patients who do not, collecting clinical data and biological samples to try to find risk factors and early signs.

  Recruiting Odense University Hospital · Odense · NCT07511283

• Comparing physical therapy during dialysis versus before dialysis for adults on hemodialysis

  This project tests whether supervised exercises done during dialysis or before dialysis help adults on hemodialysis improve physical function, quality of life, and blood measures like hemoglobin and electrolytes.

  Recruiting Ministry of Health, Kuwait · Hawalli · NCT07361146

• WeChat 'Yueya' app support for people on maintenance hemodialysis

  This project will test whether the 'Yueya' mini-program on WeChat helps people on maintenance hemodialysis follow treatment, feel better, and have fewer complications.

  Recruiting First Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07291154

• Changing magnesium and acid type in dialysis fluid to reduce clotting and immune activation

  This project tests whether changing the magnesium level and acid type in dialysis fluid can reduce immune-driven clotting and inflammation in people on maintenance hemodialysis.

  Recruiting Universitair Ziekenhuis Brussel · Brussels · NCT07206524

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.