Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study).

Summary

Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function.

Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (\< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.

The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

Conditions

• Kidney Failure, Chronic

Interventions

PROCEDURE

Extra-vascular lung water measurements by ultrasound (LW-US)

It is widely agreed that the high prevalence of patients with LV dysfunction and heart failure and the lack of simple, non-expensive, bedside techniques that may serve to estimate and monitor parameters of central hemodynamics for guiding the prescription of ultrafiltration (UF) and drug treatment is a factor of major clinical relevance. So,in patients allocated to the active arm, nephrologists register pre- and post-dialysis US-B lines whenever considered useful for volume monitoring.

OTHER

Standard protocol of fluid management in hemodialysis

The intervention consists in applying a standard clinical approach for monitoring/tailoring fluid excess in HD patients.

Sponsors & Collaborators

• Azienda Ospedaliera Bianchi-Melacrino-Morelli

  collaborator OTHER

• Universität des Saarlandes

  collaborator OTHER

• Dr. C.I. Parhon Hospital, Iasi

  collaborator UNKNOWN

• Medical University of Silesia

  collaborator OTHER

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Strasbourg

  collaborator OTHER

• Shaare Zedek Medical Center

  collaborator OTHER

• University Medical Centre Maribor

  collaborator OTHER

• IASIO Hospital - General Clinic of Kallithea

  collaborator UNKNOWN

• ASL Parma

  collaborator UNKNOWN

• University Hospital, Ioannina

  collaborator OTHER

• Wroclaw Medical University

  collaborator OTHER

• C.T.M.R. Saint-Augustin

  collaborator UNKNOWN

• Hospital Ambroise Paré Paris

  collaborator OTHER

• Centre Hospitalier FH Manhes

  collaborator OTHER

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Università degli Studi di Ferrara

  collaborator OTHER

• Istituto di Fisiologia Clinica CNR

  collaborator OTHER

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

  lead OTHER_GOV

Principal Investigators

• Carmine Zoccali, Prof · CNR-IBIM and Nephrology Unit, Reggio Calabria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2019-12-31

Completion

2020-07-31

Countries

• France
• Germany
• Greece
• Israel
• Italy
• Poland
• Romania
• Slovenia
• Spain

Study Locations