Patients on Hemodialysis for More Than 3 Months Clinical Trial
Official title:
Extravascular Lung Water Monitoring by Combined Ultrasound and Bioimpedance as a Guide for Treatment in Hemodialysis Patients
Patients will be selected from the Dialisys Centers in Iasi, Romania. Patients will be
randomized 1:1 to have a dry-weight assessment based on clinical (control) or lung US and
bioimpedance (active) guided protocol. In the control group post-dialysis dry weight will be
adjusted based on clinical criteria only (blood pressure, presence of edema, intradialytic
hypotension, cramps etc.) and in the active group the target weight will be prescribed using
lung US and bioimpedance evaluation.
In patients randomized to the active arm of the study, the US B-line score (BLS) will be
measured before dialysis and these measurements will be used to titrate ultrafiltration
prescription. In patients presenting moderate to severe lung congestion (≥15 BLS
pre-dialysis) LUS measurements will be repeated once a week until the treatment goal was
achieved (<15 BLS pre-dialysis) and once a month thereafter. The same (monthly) monitoring
frequency will be adopted also in patients without pulmonary congestion at pre-dialysis
baseline (<15 BLS). Furthermore, the use of the technique is allowed whenever its
application is deemed useful to assume clinical decisions by attending physicians. Patients
in the active arm of the study without evidence of lung congestion at baseline who developed
pulmonary congestion (≥ 15 BLS) during the trial will received the same treatment
contemplated for those with lung congestion at baseline during the trial. The treatment goal
will be pursued by ultrafiltration intensification realized within the same HD schedule (3
sessions x 4 hours/week) or, if not tolerated, by extra-dialyses, according to individual
tolerance and feasibility. In case of clinical hypovolemia (persistent cramps, hypotension
etc) additional dry-weight adjustments will be performed according to the bioimpedance
measurement, provided that the patients are below 15 BLS. This addition will be necessary in
order to be able to increase the dry-weight in patients with a persistent BLS < 15 and avoid
under perfusion.
Patients in the control arm of the study will be followed up and managed strictly with
standard criteria according to current recommendations (implying optimization of fluids
volume control on the basis of clinical criteria and the use of carvedilol, ACE
inhibitors/sartans whenever deemed necessary); the use of lung US / bioimpedanc assistance
will not be messured in these patients.
The main exclusion criteria will be the presence of severe cardiac failure (NYHA class
III-IV), past myocardial infarction, stable or unstable angina and acute coronary syndrome.
Due to bioimpedance assessment limitation patients with metallic joint prostheses, cardiac
stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations will be
excluded, as BIS cannot be accurately performed in such cases. Due to lung US measurement
limitation we will exclude patients with known persistent pleurisy, pulmonary fibrosis or
pneumectomy. Other exclusion criteria will be malignancy, active infections, temporary or
permanent catheter as a vascular access, mental incompetence and unwillingness to
participate in the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment