Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion

NCT06586060 | Not Yet Recruiting

• 1 other identifier: Master Emergency 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lung contusion is caused by blunt chest trauma, explosion injuries or a shock wave associated with penetrating trauma. These injuries damage alveolar capillaries, so blood and other fluids accumulate in the lung tissue. The excess fluid interferes with gas exchange leading to hypoxia To find out whether lung ultrasound as a non-invasive tool can be used to tailor the better fluid balance strategy to achieve higher oxygenation compared to other conventional methods in patients with lung contusion. The study will evaluate a fluid management protocol for adult patients, based on the daily assessment of B-line score (BLS) using lung ultrasound, compared to usual care. A pre-specified BLS cut-off value of 15 will be used in this study to correct fluid overload After enrolment, patients were randomly assigned to BLS-guided fluid management (active group) or standard care (control group) in a 1:1 ratio, using a computerised random-number generator. lung ultrasound guided fluid management based on BLS assessment will be conducted within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first In the active group, with every LU examination, patients will be stratified into four classes: no EVLW increase (BLS = 0-4), mild increase (BLS = 5-14), moderate increase (BLS = 15-29), or severe EVLW increase (BLS ≥ 30). In patients with no or mild EVLW increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day. In case of shocked patients with BLS \< 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of \>65 mmHg. In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of \>65 mmHg. In the control group, fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values Research outcome measures:

1. 1.Primary (main):
2. 2.Secondary (subsidiary):

Conditions

Lung Contusion

Outcome Measures

Primary Outcomes (1)

• PaO2/FiO2 ratio

  obtained from arterial blood gases

  once daily at 10 a.m. for 14 days after randomization

Study Arms (2)

LUS group

EXPERIMENTAL

lung ultrasound guided fluid management guided by B-line score (BLS). In patients with no or mild extravascular lung water (EVLW) increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day.

Other: lung ultrasound guided fluid balance strategy

control group

ACTIVE COMPARATOR

fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain.fluid and diuretics administration will be given according to the clinical judgement of the treating ICU physician. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values

Other: usual care guided fluid balance strategy

Interventions

lung ultrasound guided fluid balance strategy OTHER

Lung ultrasound (LUS) guided fluid management based on B-Line score assessment using LUS within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first In patients with BLS = 0-14, a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with BLS ≥ 15, a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used In case of shocked patients with BLS \< 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of \>65 mmHg. In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of \>65 mmHg.

LUS group

usual care guided fluid balance strategy OTHER

fluid balance management will be guided to maintain an adequate intravascular volume while minimising weight gain within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values To reach daily targeted fluid balance, furosemide-induced diuresis and RRT will be used

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• poly trauma patients with lung contusion
• isolated lung contusion
• blunt chest trauma associated with lung contusion

You may not qualify if:

• patient refusal
• pregnancy
• age less than 18.
• Patients with known pulmonary conditions that interfere with interpretation of LUS eg: pulmonary fibrosis ,persistent pleural effusion and pnemonectomy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)