Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/12/2005
Date assigned
02/02/2006
Last edited
23/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Werner Beck

ORCID ID

Contact details

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GAMBRO 99/03

Study information

Scientific title

Acronym

Hemodiafiltation (HDF) optimisation

Study hypothesis

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

Approved on 18 October 1999 by the the Freiburg Ethics Commission International (FECI)

Study design

Four-period crossover

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

End stage renal disease

Intervention

Modification of treatment mode, frequency, drawing and analysis of blood samples

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Blood concentrations of small and large molecular weight uremic solutes

Secondary outcome measures

Modelling of solute kinetics

Overall trial start date

01/01/2000

Overall trial end date

30/06/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

30/06/2000

Locations

Countries of recruitment

Germany

Trial participating centre

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Sponsor information

Organisation

Gambro Dialysatoren GmbH (Germany)

Sponsor details

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Grant by Gambro Corporate Research (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

No publication intended as of 23/10/2009

Publication citations

Additional files

Editorial Notes