- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393065
Lung Ultrasound Guided Protocol for Fluid Management for the Critically Ill Patient: a Randomized Study (LUNG US ICU)
Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: a Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inclusion criteria
- 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)
- ≤ 80 mg 40 mg iv bolus + 5 mg/h 0
- 81-160 mg 80 mg iv bolus + 10 mg/h 12.5 mg
- 161-240 mg 80 mg iv bolus + 20 mg/h 25 mg
- >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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: covic adrian, prof
- Phone Number: 1603 +40.232.301.600
- Email: accovic@gmail.com
Study Contact Backup
- Name: mihai onofriescu, prof
- Phone Number: 1603 +40.232.301.600
- Email: onomihai@yahoo.com
Study Locations
-
-
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Iași, Romania
- Recruiting
- Regional Institute of Oncology, Iasi
-
Contact:
- Siriopol Ianis
- Phone Number: +o746215967
- Email: ianis.siriopol@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
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No Intervention: Control group
control group the fluid management will not be LUS guided
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28 days survival
Time Frame: 28 days
|
all-cause mortality
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensive care unit hospitalization
Time Frame: 28 days
|
hospitalization in ICU
|
28 days
|
Duration of hospitalization
Time Frame: 28 days
|
hospitalization
|
28 days
|
Days on mechanical ventilation
Time Frame: 28 days
|
Need for mechanical ventilatory support
|
28 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PN-III-P4-ID-PCE-2016-0908
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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