Study Comparing Dryweight Determination in Hemodialysis Patients With Two Methods

NCT02348996 | Completed

• 1 other identifier: AEFDRYWEIGHT
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adequate control of extracellular volume is a major goal of renal replacement therapy in patients with chronic renal disease. Fluid overload is present in the early stages of chronic kidney disease and contributes significantly to hypertension, arteriosclerosis and high prevalence of left ventricular hypertrophy. These are associated with high rates of morbidity and mortality in this group of patients, rates on dialysis in Brazil is around17.9 % per year. Dry weight during hemodialysis remains a delicate gap between hypervolemia and hypovolemic. Many studies have shown that tight control of post - dialysis weight is related to better outcomes in short term and higher long-term survival. Many methods have been proposed for estimating the hydration status of hemodialysis patients in an objective manner, including ultrasonography of the inferior vena cava and echocardiography. However, these methods are very time-consuming and cumbersome to use in daily practice. In most dialysis centers, the dry weight is evaluated on subjective clinical criteria, with trial and error and time consuming. It was recently introduced in Brazil to monitor body composition by multifrequency bioimpedance, called Body Composition Monitor ( BCM ) manufactured by Fresenius Medical Care. The BCM is a piece of bioimpedance spectrometry using a three compartment model, able to quantify objectively and accurately the extracellular volume and hydration status of each patient by measuring body resistance to an electric current. The procedure is safe, simple and relatively inexpensive. The BCM uses multi-frequency currents (ranging from 5 to 1000 KHz ). The availability of this device evaluation of body composition which assesses the dry weight more efficiently and objectively determine a target to be achieved to prevent left ventricular hypertrophy, hypertension better manage and improve cardiovascular outcomes, motivates us to perform this study. So the goal is to compare the efficacy between bioelectrical impedance analysis and clinical evaluation for suitability of dry weight in hemodialysis patients. A prospective, randomized, crossover study, which will include all chronic renal failure patients on hemodialysis at St. Luke 's Hospital (PUC - RS), including patients with at least three months on HD and over 18 years of age. The expected primary outcome is to achieve greater accuracy in determining the state of hydration and dry weight of these patients.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in dry weight(DW) status at 10 weeks

  Volume status would match dry weight and euvolemia

  DW assessment every dialysis session for 10 weeks

Secondary Outcomes (1)

• Decreasing adverse events transdialysis

  every dialysis session for 10 weeks

Study Arms (2)

Clinical assessment

OTHER

Patients would have dry weight determined by clinical evaluation (blood pressure levels, peripheral edema, pulmonary auscultation and symptoms).

Other: Clinical evaluation

Bioimpedance

EXPERIMENTAL

Patients would have dry weight determined according to volume status with a body composition monitor (BCM)

Other: Bioimpedance

Interventions

Bioimpedance OTHER

status of overhydration determine by BCM once a week to determine dry weight

Bioimpedance

Clinical evaluation OTHER

Doctors or nurses will evaluate patients on a daily basis and determine dry weight

Clinical assessment

Eligibility Criteria

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

You may qualify if:

• hemodialysis patient over 18 years old that accepted to participate

You may not qualify if:

• Patients with metal orthopedic implants, cardiac pacemakers, patients with amputated limbs, due to the failure of evaluation of these patients by bioelectrical impedance analysis (BIA) and patients who do not accept participate in the study or decide to leave during the period of study research.

Sponsors & Collaborators

• Ana Elizabeth Prado Lima Figueiredo: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: January 28, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01