Lung Ultrasound Guided Protocol for Fluid Management for the Critically Ill Patient: a Randomized Study
NCT ID: NCT03393065
Last Updated: 2019-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2017-12-01
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of POCUS on Treatment Planning and Prognosis in the ICU
NCT06613464
Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit
NCT06295445
The CCUS Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
NCT03082326
Critical Care Ultrasound Oriented Shock Treatment in ICU
NCT03093987
Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit
NCT06729268
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\- Age 18 or older admitted to the Intensive Care Unit
Exclusion criteria
* Due to LUS measurement limitation: patients with known persistent pleurisy, pulmonary fibrosis or pneumectomy;
* Unwillingness to participate in the study.
Active arm diuretic administration algorithm
* Intravenous diuretics will be used only to decrease the BLS to \< 15;
* A stepped diuretic administration algorithm is provided below;
* Investigators may opt-out of the stepped diuretic administration algorithm if they feel it is in the best interests of the patient care;
* Intravenous diuretics can be decreased or temporarily discontinued if there is a decrease in blood pressure or an increase in creatinine that is felt to be due to a transient episode of intravascular volume depletion. After the patient has stabilized, if BLS ≥ 15, intravenous diuretics should be reinitiated until the patient's BLS is \<15.
Active arm Initial BLS ≥ 15 Diuretic dose Previous Dose Suggested dose Furosemide (/day) Furosemide (/day) Hydrochlorothiazide (/day)
1. ≤ 80 mg 40 mg iv bolus + 5 mg/h 0
2. 81-160 mg 80 mg iv bolus + 10 mg/h 12.5 mg
3. 161-240 mg 80 mg iv bolus + 20 mg/h 25 mg
4. \>240 mg 80 mg iv bolus + 30 mg/h 25 mg
At 24 hours Persistent BLS ≥ 15 Negative fluid balance \> 1000 ml - reduce current diuretic regimen if desired Negative fluid balance \< 1000 ml - maintain current diuretic regimen Positive fluid balance - advance to next step in table
Dialysis initiation AKI will be diagnosed based on changes in the serum creatinine, urine output, or both (according to the KDIGO recommendations). Creatinine measurements will be performed twice per day. Every patient will have a urinary catheter and urine output will be measured every hour.
Criteria for renal replacement therapy initiation:
Stage 3 AKI (urine output \<0.3 mL/kg/h for ≥24 h and/or \>3 fold increase in serum creatinine level compared with baseline or serum creatinine of ≥4 mg/dL with an acute increase of at least 0.5 mg/dL within 48 hours or
If any of the following absolute indications for RRT were present:
* Blood urea nitrogen level higher than 112 mg/dL;
* Serum potassium level higher than 6 mEq/L and/or with electrocardiography abnormalities;
* Urine production lower than 200 mL per 12 hours or anuria (according to the KDIGO recommendations);
* Organ edema in the presence of AKI resistant to diuretic treatment;
* A pH below 7.15 in the context of either pure metabolic acidosis (Paco2 below 35 mm Hg) or mixed acidosis (Paco2 of 50 mm Hg or more without the possibility of increasing alveolar ventilation)
* Acute pulmonary edema due to fluid overload responsible for severe hypoxemia requiring an oxygen flow rate greater than 5 liters per minute to maintain a Spo2 greater than 95% or requiring a Fio2 greater than 50% in patients receiving mechanical ventilation and despite diuretic therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Control group
control group the fluid management will not be LUS guided
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* unwillingness to participate in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Professor Adrian Covic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Adrian Covic
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regional Institute of Oncology, Iasi
Iași, , Romania
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ciumanghel A, Siriopol I, Blaj M, Siriopol D, Gavrilovici C, Covic A. B-lines score on lung ultrasound as a direct measure of respiratory dysfunction in ICU patients with acute kidney injury. Int Urol Nephrol. 2018 Jan;50(1):113-119. doi: 10.1007/s11255-017-1730-8. Epub 2017 Oct 30.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PN-III-P4-ID-PCE-2016-0908
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.