Kinetics of solute removal with on-line hemodiafiltration: influence of duration and frequency of treatment

ISRCTN	ISRCTN45403612
DOI	https://doi.org/10.1186/ISRCTN45403612
Protocol serial number	GAMBRO 99/03
Sponsor	Gambro Dialysatoren GmbH (Germany)
Funder	Grant by Gambro Corporate Research (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Werner Beck
Scientific

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Primary study design	Interventional
Study design	Four-period crossover
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Hemodiafiltation (HDF) optimisation
Study objectives	The aim of the study is to show if highly efficient and more frequent dialysis treatment is able to improve removal of low and high molecular weight uremic toxins. Clinical data on elimination and rebound kinetics of uremic toxins in a broad range of molecular weight should serve as the basis for the adjustment of kinetic models of solute removal during hemodiafiltraion treatments. These models should allow for an optimisation of hemodiafiltration treatment parameters.
Ethics approval(s)	Approved on 18 October 1999 by the the Freiburg Ethics Commission International (FECI)
Health condition(s) or problem(s) studied	End stage renal disease
Intervention	Modification of treatment mode, frequency, drawing and analysis of blood samples
Intervention type	Other
Primary outcome measure(s)	Blood concentrations of small and large molecular weight uremic solutes
Key secondary outcome measure(s)	Modelling of solute kinetics
Completion date	30/06/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	10
Key inclusion criteria	1. Stable patients with renal end stage disease being on hemodialysis for at least six months 2. Residual urine volume less than 200 ml per day 3. Ages betweeen 18 and 75 years 4. Body dry weight between 60 and 80 kg 5. Written consent 6. Well functioning vascular access
Key exclusion criteria	1. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 2. Miscellaneous acute or chronic infections 3. Known coagulation disturbances 4. Known incompliance with respect to fluid restriction
Date of first enrolment	01/01/2000
Date of final enrolment	30/06/2000

Holger-Crafoord-Str. 26

Hechingen
72379
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan