Status:
COMPLETED
Optimizing Fluid Status
Lead Sponsor:
Francisco Maduell
Collaborating Sponsors:
Fresenius Medical Care Europe
Conditions:
Hypotension During Dialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Title of study: Optimizing Fluid Status Study code: HD-IIT-01-E Study design: Prospective open design in study centre at two locations Applied medical device: Body Composition Monitor (BCM) for det...
Eligibility Criteria
Inclusion
- Chronic renal failure stage V
- Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
- Ability to understand the nature and requirements of the study
- Age: at least 18 years
- Signed informed consent.
Exclusion
- Interventional clinical study during the preceding 30 days or previous participation in the same study
- Acute or chronic infection (HIV, Hepatitis B or C, ...)
- Severe disease (malignant tumour, tuberculosis ...)
- Usually single needle HD
- Problems with shunt or high recirculation,
- Severe intra-dialytic blood pressure instability in the last month
- Instable angina pectoris
- Major amputation at arm or leg, or a pacemaker.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01492634
Start Date
November 1 2011
End Date
February 1 2012
Last Update
February 28 2014
Active Locations (1)
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1
Dialysis Units, Hospital Clínic
Barcelona, Barcelona, Spain, 08036