Optimizing Fluid Status

Hypotension During Dialysis Clinical Trial

Official title:

Clinical Investigation Plan Optimizing Fluid Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492634
• Other study ID #: HD-IIT-01-E
• Status: Completed
• Phase: N/A
• First received: December 7, 2011
• Last updated: February 27, 2014
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2011
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Dialysis

Intervention

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.

Locations

Country	Name	City	State
Spain	Dialysis Units, Hospital Clínic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Maduell	Fresenius Medical Care Europe

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Moissl U, Arias-Guillén M, Wabel P, Fontseré 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-individual difference in TAFO between study start and study end		3 months	Yes
Secondary	Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)		3 months	No
Secondary	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	No
Secondary	SF 36 total score and sub-scores as calculated according to official guidelines,		3 months	No
Secondary	BNP		3 months	No
Secondary	Blood pressure		3 months	No
Secondary	laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).		3 months	No
Secondary	Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)		3 months	No
Secondary	Change from baseline in intra-dialytic events (hypotension, cramps)		3 months	No
Secondary	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	No
Secondary	Hospitalisation		3 months	No