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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04633629
Other study ID # 38RC20.328
Secondary ID 2020-A02413-36
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2020
Est. completion date October 2021

Study information

Verified date November 2020
Source University Hospital, Grenoble
Contact Perrine Dumanoir, Doctor
Phone +33476767098
Email pdumanoir@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.


Description:

EPPICA is an observational and prospective cohort study. The study goal is to evaluate LUS aspect evolution according to diuretics dosage in patients hospitalized for acute heart failure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 94
Est. completion date October 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute heart failure diagnosed by a senior physician in the medical department, with a confirmation of a second senior physician. - Hospitalised in the medical department. - No objection from the patient of his trusted person. Exclusion Criteria: - Administrative supervision or deprived of their liberty - Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis) - Chronically dialysed

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lung ultrasound
We will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

References & Publications (6)

Coiro S, Rossignol P, Ambrosio G, Carluccio E, Alunni G, Murrone A, Tritto I, Zannad F, Girerd N. Prognostic value of residual pulmonary congestion at discharge assessed by lung ultrasound imaging in heart failure. Eur J Heart Fail. 2015 Nov;17(11):1172-81. doi: 10.1002/ejhf.344. Epub 2015 Sep 29. — View Citation

Gargani L, Pang PS, Frassi F, Miglioranza MH, Dini FL, Landi P, Picano E. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: a lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4. — View Citation

Öhman J, Harjola VP, Karjalainen P, Lassus J. Focused echocardiography and lung ultrasound protocol for guiding treatment in acute heart failure. ESC Heart Fail. 2018 Feb;5(1):120-128. doi: 10.1002/ehf2.12208. Epub 2017 Sep 28. — View Citation

Platz E, Merz AA, Jhund PS, Vazir A, Campbell R, McMurray JJ. Dynamic changes and prognostic value of pulmonary congestion by lung ultrasound in acute and chronic heart failure: a systematic review. Eur J Heart Fail. 2017 Sep;19(9):1154-1163. doi: 10.1002/ejhf.839. Epub 2017 May 30. Review. — View Citation

Rusu DM, Siriopol I, Grigoras I, Blaj M, Ciumanghel AI, Siriopol D, Nistor I, Onofriescu M, Sandu G, Cobzaru B, Scripcariu DV, Diaconu O, Covic AC. Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial. Trials. 2019 Apr 25;20(1):236. doi: 10.1186/s13063-019-3345-0. — View Citation

Volpicelli G, Caramello V, Cardinale L, Mussa A, Bar F, Frascisco MF. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi: 10.1016/j.ajem.2007.09.014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lung ultrasound aspect according to diuretics dosage evolution. B-lines number on LUS LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Secondary Lung ultrasound aspect according to clinical signs of acute heart failure (crackling auscultation or lower limbs edema) B-lines number on LUS LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
Secondary Lung ultrasound aspect according to acute kidney injury (based on plasmatic creatinine levels). B-lines number on LUS LUS will be performed daily during the whole hospitalisation length (on average 7 days). Plasmatic creatinine measure will be performed at least weekly.
Secondary Lung ultrasound aspect according to early prognosis (re-hospitalisation or mortality within 30 days after discharge) B-lines number on LUS LUS will be performed daily during the whole hospitalisation length (on average 7 days). Patient will be called 30 days after discharge.
Secondary Feasibility of daily LUS in medical department. Number of LUS performed compared to number of hospitalisation days. LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Secondary Interest of LUS compared to clinical examination at discharge. B-lines at discharge compared to clinical signs of acute heart failure. LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
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