Extravascular Lung Water Monitoring by Combined Ultrasound and Bioimpedance as a Guide for Treatment in Hemodialysis Patients
Keywords
Abstract
Dates
Last Verified: | 02/29/2016 |
First Submitted: | 03/18/2013 |
Estimated Enrollment Submitted: | 03/19/2013 |
First Posted: | 03/20/2013 |
Last Update Submitted: | 02/29/2016 |
Last Update Posted: | 03/01/2016 |
Actual Study Start Date: | 02/28/2013 |
Estimated Primary Completion Date: | 07/31/2015 |
Estimated Study Completion Date: | 07/31/2015 |
Condition or disease
Intervention/treatment
Other: active arm of the study
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: active arm of the study The number of ultrasound lung comets (ULC) will directly adjust the prescribed post-hemodialysis dry weight. The US B-line score (BLS) will be measured before dialysis. 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. monthly monitoring frequency will be adopted also in patients without pulmonary congestion (BLS <15). Patients 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. | Other: active arm of the study In the active arm of the study, the number of ultrasound lung comets (ULC) will directly adjust the prescribed post-hemodialysis dry weight. See study flowchart on page 1.
If the patient does not tolerate the intervention (as described above), he will continue the study in the "medication arm", where the actual intervention in stopped, and extra cardio-protective drugs are added to the medication. |
No Intervention: Standard care arm In the control arm of the study, the dry weight will be assessed only clinically.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 / bioimpedance assistance was not allowed in these patients. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - patients in hemodialysis for more than 3 months, that have no absolute contraindication for for performing bioimpedance measurements (amputation, stent, pregnancy, severe ascites) and ultrasound lung comets measurements (persistent pleuresia, pulmonary fibrosis, pneumectomy). Exclusion Criteria: - Patients with metallic joint prostheses, cardiac pacemakers, decompensated cirrhosis, limb amputations and severe conditions with life expectations <1 year |
Outcome
Primary Outcome Measures
1. All-cause mortality [2 years]
Secondary Outcome Measures
1. Left ventricular mass measured by echocardiography [2 years]
Other Outcome Measures
1. Volume measures [2 years]
2. Health-related quality of life (HRQOL) [2 years]