CompletedNot Applicable

Optimizing Fluid Status

Spain56 participantsStarted 2011-11

Plain-language 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 determination of fluid overload and dry weight Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre. Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the: * time averaged fluid overload (TAFO), * proportion of patients with severe overhydration OH \> 2.5 L,or OH/ECW \> 15 %) * proportion of dehydrated patients (OH \< -1.0 L, or OH \< -7 %), * mean overhydration, * variance of overhydration, * time outside the reference range (-1.0L \< OH \< 2.5L). Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes Patients: 60 patients

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

intra-individual difference in TAFO between study start and study end

Timeframe: 3 months

Trial details

NCT IDNCT01492634

SponsorFrancisco Maduell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

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