Optimizing Fluid Status

This study has been completed.

Sponsor:

Collaborator:

Fresenius Medical Care Europe

Information provided by (Responsible Party):

Francisco Maduell, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT01492634

First received: December 7, 2011

Last updated: April 19, 2012

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 7, 2011
Last Updated Date	April 19, 2012
Start Date ^ICMJE	November 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2011)	intra-individual difference in TAFO between study start and study end [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01492634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 13, 2011)	Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH) [ Time Frame: 3 months ] [ Designated as safety issue: No ] Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L) [ Time Frame: 3 months ] [ Designated as safety issue: No ] SF 36 total score and sub-scores as calculated according to official guidelines, [ Time Frame: 3 months ] [ Designated as safety issue: No ] BNP [ Time Frame: 3 months ] [ Designated as safety issue: No ] Blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ] laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin). [ Time Frame: 3 months ] [ Designated as safety issue: No ] Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication) [ Time Frame: 3 months ] [ Designated as safety issue: No ] Change from baseline in intra-dialytic events (hypotension, cramps) [ Time Frame: 3 months ] [ Designated as safety issue: No ] Change from baseline in Residual Renal Function [ Time Frame: 3 months ] [ Designated as safety issue: No ] Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks. Hospitalisation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Optimizing Fluid Status
Official Title ^ICMJE	Clinical Investigation Plan Optimizing Fluid Status
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 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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Hypotension During Dialysis
Intervention ^ICMJE	Other: Prescription of post-dialytic weight based on BCM device Prescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor). The time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L. Prescription steps will be calculated weekly for all study patients. TAFO < -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO > 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week. Other Name: BCM or Body Composition Monitor Fresenius Medical Care
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	56
Completion Date	February 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01492634
Other Study ID Numbers ^ICMJE	HD-IIT-01-E
Has Data Monitoring Committee	No
Responsible Party	Francisco Maduell, Hospital Clinic of Barcelona
Study Sponsor ^ICMJE	Francisco Maduell
Collaborators ^ICMJE	Fresenius Medical Care Europe
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Clinic of Barcelona
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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