N/A N=34 Randomized Triple-blind Treatment

Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT03301740 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg) — 578; 571 Number of occurrences — p=0.5

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: UF profiling during HD (Other); Conventional HD (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg)	578; 571	0.5
PRIMARY Pre- to Post-hemodialysis Treatment Change in Troponin T Level in ng/mL at Weeks 3, 7, 11, and 15, Using Mixed Model Analysis	12.3; 11.3	0.2
PRIMARY Occurrence of a ≥10% Troponin T Percentage Rise From Pre- to Post-hemodialysis Treatment	64; 63	0.1
PRIMARY Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)	0.9; 1.3	0.2
SECONDARY Nadir Systolic Blood Pressure During Hemodialysis in mmHg	104.9; 102.1	0.9
SECONDARY 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)	578; 571	0.8
SECONDARY Occurrence of Patient-reported Clinically Important Cramping During Dialysis (Clinically Important Cramping Defined as Moderate, Severe, or Very Severe Cramping)	245; 242	0.9
SECONDARY 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)	245; 242	0.5
SECONDARY 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)	245; 242	1.0
SECONDARY 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)	245; 242	0.04 sig
SECONDARY 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)	245; 242	0.3
SECONDARY Occurrence of Patient-reported Clinically Important Chest Pain During Dialysis (Clinically Important Chest Pain Defined as Moderate, Severe, or Very Severe Chest Pain)	245; 242	1.0
SECONDARY 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)	245; 242	0.7
SECONDARY 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)	245; 242	0.2
SECONDARY Occurrence of Patient-reported Clinically Important Headache During Dialysis (Clinically Important Headache Defined as Moderate, Severe, or Very Severe Headache)	245; 242	0.8
SECONDARY Occurrence of Patient-reported Clinically Important Itching During Dialysis (Clinically Important Itching Defined as Moderate, Severe, or Very Severe Itching)	245; 242	0.02 sig
SECONDARY Occurrence of Patient-reported Clinically Important Restless Legs During Dialysis (Clinically Important Restless Legs Defined as Moderate, Severe, or Very Severe Restless Legs)	245; 242	0.7
SECONDARY 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)	245; 242	0.5

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03301740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.