Kinetics of solute removal with on-line hemodiafiltration: influence of duration and frequency of treatment
| ISRCTN | ISRCTN45403612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45403612 |
| Secondary identifying numbers | GAMBRO 99/03 |
- Submission date
- 02/12/2005
- Registration date
- 02/02/2006
- Last edited
- 23/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Dr Werner Beck
Scientific
Scientific
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
Study information
| Study design | Four-period crossover |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Blood concentrations of small and large molecular weight uremic solutes |
| Secondary outcome measures | Modelling of solute kinetics |
| Overall study start date | 01/01/2000 |
| Completion date | 30/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
72379
Germany
Sponsor information
Gambro Dialysatoren GmbH (Germany)
Industry
Industry
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
"ROR" |
https://ror.org/05jgtkc28 |
|---|
Funders
Funder type
Industry
Grant by Gambro Corporate Research (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
