Clinical trial NCT03301740: Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Official title: Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Ultrafiltration profiling
Hemodialysis
Dialysis
Cardiovascular outcomes
Patient-reported outcomes
Crossover study design
End Stage Renal Disease
Ultrafiltration
Echocardiogram
Blood pressure
Hypotension
Symptoms
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-10-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a 4-phase crossover trial in which participants are successively alternated between conventional HD and conventional HD + linear UF profiling across 4 phases with intervening wash-out periods. The study compares conventional HD (the participant's standard HD prescription with no UF profiling) to conventional HD + linear UF profiling. Participants will be randomly allocated to conventional HD or conventional HD + linear UF profiling for phase 1. Participants will undergo 9 treatments during each phase for a total of 18 conventional HD treatments and 18 UF profiled treatments. Participants will undergo 3 wash-out HD treatments between phases.
Primary purpose: TREATMENT

Brief summary: The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm without necessitating reduction in interdialytic fluid intake or longer HD treatments. To date, UF profiling has not been adequately studied independent of sodium profiling.

This study investigates the comparative effect of UF profiling versus non-profiled conventional HD on select cardiovascular and patient-reported outcomes. Participants will complete two phases of UF profiling and two phases of conventional HD and will act as their own controls.


Eligibility criteria: Inclusion Criteria:

* UF rate \>10 mL/h/kg in \>30% of treatments in a 30-day screening period (require ≥6 outpatient HD treatments in this period)
* Age 18-85 years
* Ability to converse comfortably in English or Spanish
* Receipt of in-center maintenance HD at Carolina Dialysis clinics in Carrboro or Siler City, North Carolina
* ≥90 days on HD
* Free of bloodstream infection during screening period
* Willingness to undergo all study testing
* Evidence of a signed and dated informed consent document

Exclusion Criteria:

* Systolic BP unable to be measured by arm cuff
* \>1 hospitalization during screening period
* Unstable angina per treating nephrologist
* End-stage cirrhosis per treating nephrologist
* New York Heart Association class IV heart failure per treating nephrologist
* Pregnant
* More than 4 times per week HD
* Incarcerated
* Anticipated kidney transplant within 6 months per treating nephrologist
* Non-adherence to HD prescription (\>2 unexplained absences during screening period)
* Sodium profiling or UF profiling in standard HD prescription
* Decisionally challenged, unable to provide informed consent

Primary outcomes:
measure: Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg)
timeFrame: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks
measure: Pre- to Post-hemodialysis Treatment Change in Troponin T Level in ng/mL at Weeks 3, 7, 11, and 15, Using Mixed Model Analysis
timeFrame: Weeks 3, 7, 11, and 15
measure: Occurrence of a ≥10% Troponin T Percentage Rise From Pre- to Post-hemodialysis Treatment
timeFrame: Weeks 3, 7, 11, and 15
measure: Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)
timeFrame: Weeks 3 and 7
Secondary outcomes:
measure: Nadir Systolic Blood Pressure During Hemodialysis in mmHg
timeFrame: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks
measure: Occurrence of Failed Target Weight Achievement (Failed Target Weight Achievement Defined as a Difference in Prescribed Target Weight and Post-dialysis Weight That is >1 kg or <-1 kg)
timeFrame: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks
measure: Occurrence of Patient-reported Clinically Important Cramping During Dialysis (Clinically Important Cramping Defined as Moderate, Severe, or Very Severe Cramping)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Nausea or Upset Stomach During Dialysis (Clinically Important Nausea or Upset Stomach Defined as Moderate, Severe, or Very Severe Nausea or Upset Stomach)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Vomiting or Throwing up During Dialysis (Clinically Important Vomiting or Throwing up Defined as Moderate, Severe, or Very Severe Vomiting or Throwing up)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Dizziness or Lightheadedness During Dialysis (Clinically Important Dizziness or Lightheadedness Defined as Moderate, Severe, or Very Severe Dizziness or Lightheadedness)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Racing Heart or Heart Palpitations During Dialysis (Clinically Important Racing Heart or Heart Palpitations Defined as Moderate, Severe, or Very Severe Racing Heart or Heart Palpitations)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Chest Pain During Dialysis (Clinically Important Chest Pain Defined as Moderate, Severe, or Very Severe Chest Pain)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Shortness of Breath During Dialysis (Clinically Important Shortness of Breath Defined as Moderate, Severe, or Very Severe Shortness of Breath)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Thirst or Dry Mouth During Dialysis (Clinically Important Thirst or Dry Mouth Defined as Moderate, Severe, or Very Severe Thirst or Dry Mouth)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Headache During Dialysis (Clinically Important Headache Defined as Moderate, Severe, or Very Severe Headache)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Itching During Dialysis (Clinically Important Itching Defined as Moderate, Severe, or Very Severe Itching)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Restless Legs During Dialysis (Clinically Important Restless Legs Defined as Moderate, Severe, or Very Severe Restless Legs)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
measure: Occurrence of Patient-reported Clinically Important Tingling or Feeling of Pins and Needles During Dialysis (Clinically Important Tingling or Feeling of Pins and Needles Defined as Moderate, Severe, or Very Severe Tingling or Feeling of Pins and Needles)
timeFrame: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: Carolina Dialysis - Carrboro
state: North Carolina
city: Siler City
country: United States
facility: Carolina Dialysis - Siler City
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Flythe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flythe JE, Tugman MJ, Narendra JH, Assimon MM, Li Q, Wang Y, Brunelli SM, Hinderliter AL. Effect of ultrafiltration profiling on outcomes among maintenance hemodialysis patients: a pilot randomized crossover trial. J Nephrol. 2021 Feb;34(1):113-123. doi: 10.1007/s40620-020-00862-6. Epub 2020 Sep 25.