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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.
Inclusion criteria
- Age 18 or older admitted to the Intensive Care Unit
Exclusion criteria
Active arm diuretic administration algorithm
Active arm Initial BLS ≥ 15 Diuretic dose Previous Dose Suggested dose Furosemide (/day) Furosemide (/day) Hydrochlorothiazide (/day)
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group pulmonary congestion | Experimental | 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. |
|
| Control group | No Intervention | control group the fluid management will not be LUS guided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid management guided by BLS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28 days survival | all-cause mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit hospitalization | hospitalization in ICU | 28 days |
| Duration of hospitalization | hospitalization | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| covic adrian, prof | Contact | +40.232.301.600 | 1603 | accovic@gmail.com |
| mihai onofriescu, prof | Contact | +40.232.301.600 | 1603 | onomihai@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Institute of Oncology, Iasi | Recruiting | Iași | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29086342 | Background | 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. | |
| 31023358 | Derived | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
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Results of the lung ultrasounds will not be made publicly available
| Days on mechanical ventilation | Need for mechanical ventilatory support | 28 days |