Critical IllnessLUNG US ICUNCT03393065
Lung Ultrasound Guided Protocol for Fluid Management for the Critically Ill Patient: a Randomized Study
A study testing Fluid management guided by BLS in people with Critical Illness, run by Professor Adrian Covic at 1 site in Romania.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Fluid management guided by BLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older admitted to the Intensive Care Unit
Who cannot join
- known persistent pleurisy, pulmonary fibrosis or pneumectomy (due to lung ultrasonography limitations);
- unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Regional Institute of Oncology, Iasi
Iași
Siriopol Ianis, +o746215967, ianis.siriopol@gmail.com
About this study
Official title: Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: a Randomized Study
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Fluid management guided by BLS
- Keywords
- lung ultrasounds, fluid managements, critical care patients
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid management guided by BLSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fluid management guided by BLS |
| Control group | No intervention | control group the fluid management will not be LUS guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days survival
all-cause mortality
Measured: 28 days
Secondary outcomes (3)
Intensive care unit hospitalization
hospitalization in ICU
Measured: 28 days
Duration of hospitalization
hospitalization
Measured: 28 days
Days on mechanical ventilation
Need for mechanical ventilatory support
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Dec 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Adrian Covic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393065
- Sponsor's protocol ID
- PN-III-P4-ID-PCE-2016-0908
- Acronym
- LUNG US ICU
- Status last verified
- Feb 2019
- First submitted
- 6 Dec 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29086342Rusu 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.
PubMed 31023358
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: a Randomized Study
- ClinicalTrials.gov ID
- NCT03393065
- Acronym / sponsor ID
- LUNG US ICU / PN-III-P4-ID-PCE-2016-0908
- Conditions
- Critical Illness
- Keywords
- lung ultrasounds, fluid managements, critical care patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Professor Adrian CovicUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| intervention group pulmonary congestion | Experimental | Other: Fluid management guided by BLSin 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 or older admitted to the Intensive Care Unit
Key exclusion criteria (2 listed)
- known persistent pleurisy, pulmonary fibrosis or pneumectomy (due to lung ultrasonography limitations);
- unwillingness to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid management guided by BLSWe 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. | Other | intervention group pulmonary congestion |
Primary outcome
28 days survival
Time frame: 28 days
all-cause mortality
3 secondary outcomes
Intensive care unit hospitalization
Time frame: 28 days
Duration of hospitalization
Time frame: 28 days
Days on mechanical ventilation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 29086342Ciumanghel 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.
- Derived from this study: PubMed 31023358Rusu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid management guided by BLS in people with Critical Illness, run by Professor Adrian Covic at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact covic adrian, prof (+40.232.301.600 ext. 1603, accovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.