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Lung Ultrasound Guided Protocol for Fluid Management for the Critically Ill Patient: a Randomized Study (LUNG US ICU)

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ClinicalTrials.gov Identifier: NCT03393065
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

Brief Summary:
In the Intensive Care Unit (ICU) this bedside method of assessing lung congestion could be useful in a better management of the critically ill patients with a wide range of respiratory failure causes (Acute Respiratory Distress Syndrome, COPD, acute pulmonary edema, pneumonia etc.). Fluid management is a key issue in the ICU where patients are either hemodynamic unstable and/or mechanically ventilated. A randomized study is proposed where in the interventional arm the fluid management (volume replacement, diuretics, use of vasopressors) will be guided using the BLS as a sign of pulmonary congestion.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Fluid management guided by BLS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized in two groups: in the intervention group pulmonary congestion, as assessed by the BLS will guide the fluid management, with a target of below 15 BLS. In the control group the fluid management will not be LUS guided. In both groups, further complementary fluid assessment methods will be performed blindly from the investigators: body composition assessment by bioimpedance and biochemical panel consisting in cardiac biomarkers (NTproBNP, cTnT) and inflamatory markers (IL-6).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Results of the lung ultrasounds will not be made publicly available
Primary Purpose: Treatment
Official Title: Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: a Randomized Study
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: intervention group pulmonary congestion
in the intervention group pulmonary congestion, as assessed by the BLS will guide the diuretic and fluid management, with a target of below 15 BLS. Furthermore, in the active arm, in the patients who will require a renal replacement therapy (RRT), BLS will be used to further guide the dialysis fluid prescription.
Other: Fluid management guided by BLS
We propose a randomized study where in the interventional arm the fluid management (volume replacement, diuretics, use of vasopressors) will be guided using the BLS as a sign of pulmonary congestion.

No Intervention: Control group
control group the fluid management will not be LUS guided



Primary Outcome Measures :
  1. 28 days survival [ Time Frame: 28 days ]
    all-cause mortality


Secondary Outcome Measures :
  1. Intensive care unit hospitalization [ Time Frame: 28 days ]
    hospitalization in ICU

  2. Duration of hospitalization [ Time Frame: 28 days ]
    hospitalization

  3. Days on mechanical ventilation [ Time Frame: 28 days ]
    Need for mechanical ventilatory support



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older admitted to the Intensive Care Unit

Exclusion Criteria:

  • known persistent pleurisy, pulmonary fibrosis or pneumectomy (due to lung ultrasonography limitations);
  • unwillingness to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393065


Contacts
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Contact: covic adrian, prof +40.232.301.600 ext 1603 accovic@gmail.com
Contact: mihai onofriescu, prof +40.232.301.600 ext 1603 onomihai@yahoo.com

Locations
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Romania
Regional Institute of Oncology, Iasi Recruiting
Iași, Romania
Contact: Siriopol Ianis    +o746215967    ianis.siriopol@gmail.com   
Sponsors and Collaborators
Professor Adrian Covic

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Adrian Covic, Clinical Professor, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03393065    
Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0908
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy:
lung ultrasounds
fluid managements
critical care patients
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes