Comparison of the efficacy of two dialysis filters in removing larger molecules that accumulate in acute renal failure

Comparison of middle molecule clearance and removal between a new high cut-off dialyzer to an established dialyzer - a clinical cross-over comparison in extended dialysis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88486733

Enrollment

Registered

2012-05-01

Start date

2012-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury, renal replacement therapy Injury, Occupational Diseases, Poisoning Injury of kidney

Interventions

In this prospective randomized cross-over trial every participating patient received two consecutive extended dialysis sessions starting in random order either with the EMiC2 or the Ultraflux AV 1000S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females 2. Aged > 18 years 3. Patients in the intensive care unit suffering from acute kidney injury [stage Acute Kidney Injury Network (AKIN) III], i.e. need for renal replacement therapy 4. Treatment using the 90 L GENIUS batch dialysis system 5. Signed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant and nursing patients 2. Patients participating in a different study (other than observational) 3. All conditions deemed to justify exclusion by the recruiting physician

Design outcomes

Primary

Measure	Time frame
1. Dialyser clarance of middle molecules 2. Total amount of middle molecules in the combined spent dialysate and ultrafiltrate dialyzer clearance measured 30 min after start of treatment for the quantified substances according to equation 1 using the patients? hematocrit level (Hct) at the time of clearance sampling. Eq. 1: Kplasma = QB x (1 ? Hct/100) x ((Cart ? Cven)/Cart) 3. Reduction ratio (RR) determined for beta2-microglobulin, creatinine, cystatin c and urea. Therefore, blood samples will be collected right before the start (Cpre) as well as at the end (Cpost) of the treatment. Calculations of RR executed according to equation 2. Eq. 2: RR = (Cpost ? Cpre)/Cpre x 100 Samples of the total spent dialysate will be drawn at the end of the treatment.	—

Measure

Time frame

1. Dialyser clarance of middle molecules 2. Total amount of middle molecules in the combined spent dialysate and ultrafiltrate dialyzer clearance measured 30 min after start of treatment for the quantified substances according to equation 1 using the patients? hematocrit level (Hct) at the time of clearance sampling. Eq. 1: Kplasma = QB x (1 ? Hct/100) x ((Cart ? Cven)/Cart) 3. Reduction ratio (RR) determined for beta2-microglobulin, creatinine, cystatin c and urea. Therefore, blood samples will be collected right before the start (Cpre) as well as at the end (Cpost) of the treatment. Calculations of RR executed according to equation 2. Eq. 2: RR = (Cpost ? Cpre)/Cpre x 100 Samples of the total spent dialysate will be drawn at the end of the treatment.

—

Secondary

Measure	Time frame
Albumin loss Total loss of albumin by adding the albumin values in the total spent dialysate and ultrafiltrate. For concentrations below the detection limit of 1.1 mg/dl, an albumin concentration of 1.1 mg/dl was assumed. Eq. 3: Alb = Calb(dialysate) x Vdialysate + Calb(ultrafiltrate) x Vultrafiltrate	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026