Optimizing Fluid Status

Clinical Investigation Plan Optimizing Fluid Status

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

Study Overview

• Status: Completed
• Conditions: Hypotension During Dialysis
• Intervention / Treatment: Other: Prescription of post-dialytic weight based on BCM device

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Dialysis Units, Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intra-individual difference in TAFO between study start and study end	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)		3 months
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)		3 months
SF 36 total score and sub-scores as calculated according to official guidelines,		3 months
BNP		3 months
Blood pressure		3 months
laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).		3 months
Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)		3 months
Change from baseline in intra-dialytic events (hypotension, cramps)		3 months
Change from baseline in Residual Renal Function	Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.	3 months
Hospitalisation		3 months

Collaborators and Investigators

• Sponsor: Francisco Maduell
• Collaborators: Fresenius Medical Care Europe

Publications and helpful links

General Publications

• Moissl U, Arias-Guillen M, Wabel P, Fontsere N, Carrera M, Campistol JM, Maduell F. Bioimpedance-guided fluid management in hemodialysis patients. Clin J Am Soc Nephrol. 2013 Sep;8(9):1575-82. doi: 10.2215/CJN.12411212. Epub 2013 Aug 15.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 15, 2011

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: bioimpedance; overhydration; dry weight
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: HD-IIT-01-E