Volume Status Clinical Trial
— BIAHDOfficial title:
Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | December 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - older than 18-year - on chronic hemodialysis for more than 3 months Exclusion Criteria: - 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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Grigore T. Popa University of Medicine and Pharmacy |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Arterial stiffness | Arterial stiffness was evaluated by applanation tonometry, measuring pulse wave velocity, and was done with a SphygmoCor® device (AtCor Medical, Westmead, Sydney, Australia). Measurements were performed in both arms at baseline, end of intervention (2,5 years) and at the end of the study (3,5 years). |
3,5 years | No |
Secondary | Blood pressure values | In both arms, blood pressure was measured predialysis every 3 months and noted as a mean of the previous 3 predialysis BP values. | 2,5 years | No |
Secondary | Overhydration | Overhydration was evaluated in both arms of the study using the Body Composition Monitor (BCM device), every 3 months. Overhydration was quantified as Relative fluid overload (RFO = overhydration/ total body water - as measured by the BCM. | 2,5 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06090812 -
Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis
|
||
Completed |
NCT05717556 -
Success of Internal Jugular Vein Catheterization
|
N/A | |
Recruiting |
NCT06379347 -
HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound
|
||
Completed |
NCT01263977 -
Thermodilution - Controlled Management of Volume Therapy in Septic Shock
|
N/A |