Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients

NCT01828658 | Completed

• 1 other identifier: BCM0913
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.

Conditions

Haemodialyzed Patients; Volume Status

Keywords

hemodialysis; fluid management; bioimpedance; mortality; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  We assessed all-cause mortality in the two arms of the study at the end of intervention period.

  2,5 years follow-up

Secondary Outcomes (3)

• Arterial stiffness

  3,5 years

• Blood pressure values

  2,5 years

• Overhydration

  2,5 years

Study Arms (2)

Clinical (control)

NO INTERVENTION

In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment.

Bioimpedance arm

ACTIVE COMPARATOR

Strict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months.

Other: Strict bioimpedance guided dry weight prescription

Interventions

Strict bioimpedance guided dry weight prescription OTHER

Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).

Bioimpedance arm

Eligibility Criteria

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

You may qualify if:

• older than 18-year
• on chronic hemodialysis for more than 3 months

You may not qualify if:

• \- life expectancy of less than 1 year
• Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):
• severe ascites (decompensated liver failure)
• limb amputations
• cardiac stent, pacemaker or defibrillator
• hip prosthetic
• pregnancy
• mental deficiency (impossibility to give consent)

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Related Publications (1)

• Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.

  PMID: 24583055 DERIVED

Study Officials

• Adrian Covic, Professor

  University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 10, 2013
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 16, 2013

Record last verified: 2013-10