Effect of Dry-weight Probing Guided by Lung-Ultrasound on Ambulatory Blood Pressure and Arterial Stiffness in Hemodialysis Patients (LUST Sub-Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03058874
• Date of registration: 07/02/2017
• Prospective Registration: No
• Primary sponsor: Carmine Zoccali
• Public title: Effect of Dry-weight Probing Guided by Lung-Ultrasound on Ambulatory Blood Pressure and Arterial Stiffness in Hemodialysis Patients (LUST Sub-Study) LUST ABPM
• Scientific title: The Effect of a Dry-weight Probing Guided by Lung Ultrasound on Ambulatory Blood Pressure and Arterial Stiffness in Hemodialysis Patients. A LUST Sub-study.
• Date of first enrolment: September 1, 2016
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03058874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Greece, Italy, Slovenia

Contacts

• Name: Pantelis A Sarafidis, MD, MSc, PhD
• Affiliation: Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Dialysis vintage > 3 months

- A history of hypertension, confirmed by valid Home BP readings

- Written consent to take part in the study

Exclusion Criteria:

- Cancer or other advanced non cardiac disease or co-morbidity (e.g. end-stage liver
failure) imposing a very poor short-term prognosis

- Active infections or relevant inter-current disease

- Inadequate lung scanning and echocardiographic studies

- Hemodynamic instability during dialysis session that require intravenous fluid
administration to restore BP, in over 30% of sessions during the past 3 months

- Patients with modification of their dry weight and antihypertensive treatment during
one month prior to study enrolment

- Nonfunctional arteriovenous fistula in the contralateral arm of the one used as
vascular access for the hemodialysis session

- Patients with Home BP readings >180/110 mmHg

- Patients with history of drug or alcohol abuse or known severe mental disorder

- Pregnancy at study entry or during study period



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Hemodialysis

Hypertension

Intervention(s)

Device: Extra-vascular lung water measurements by ultrasound

Other: Standard protocol of fluid management in hemodialysis

Primary Outcome(s)

Difference between groups in changes in 48-hour Brachial Systolic Blood Pressure, obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Secondary Outcome(s)

Difference between groups in changes in 48-hour Aortic Diastolic Blood Pressure, obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in 48-hour Aortic Systolic Blood Pressure, obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in ambulatory augmentation index (AIx), obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in echocardiographic indices of left ventricular function [Time Frame: 0, 2, 12 months]

Difference between groups in changes in AIx, obtained with the Sphygmocor device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in 48-hour Brachial Diastolic Blood Pressure, obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in Body composition assessed with bioelectrical impedance analysis [Time Frame: 0, 2, 12 months]

Difference between groups in changes in ambulatory pulse pressure (PP), obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in ambulatory pulse wave velocity (PWV), obtained with the Mobilograph device [Time Frame: 0, 2, 12 months]

Difference between groups in changes in PWV, obtained with the Sphygmocor device [Time Frame: 0, 2, 12 months]

Secondary ID(s)

ELKE 93367

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Clinical Centre of Maribor, Slovenia

Aristotle University Of Thessaloniki

CNR-IBIM Clinical Epidemiology of Renal Diseases and Hypertension Unit, Reggio, Italy