Optimizing Fluid Status

NCT01492634 | Completed

• 1 other identifier: HD-IIT-01-E
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Hypotension During Dialysis

Keywords

bioimpedance; overhydration; dry weight

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (10)

• 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

Interventions

Prescription of post-dialytic weight based on BCM device OTHER

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.

Also known as: BCM or Body Composition Monitor Fresenius Medical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic renal failure stage V
• Ability to understand the nature and requirements of the study
• Age: at least 18 years
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Maduell: lead
• Fresenius Medical Care Europe: collaborator

Study Sites (1)

Dialysis Units, Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 23949235 RESULT

MeSH Terms

Conditions

Water Intoxication

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Head of Dialysis Section

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 15, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2011-12

Locations

ES (1)