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The aim of our study is to compare between the effect of nebulized and intravenous injection of hypertonic saline 3% on the outcome of patients with acute respiratory distress syndrome.
Acute Respiratory Distress Syndrome (ARDS) is a life threatening form of respiratory failure, characterized by acute, diffuse, inflammatory lung injury that results in increased alveolar capillary permeability and the development of non-hydrostatic pulmonary edema.
Clinically, ARDS manifests as marked hypoxemia and respiratory distress; patients often progress to respiratory failure that requires invasive mechanical ventilation in the intensive care unit.
No specific pharmacological treatment is available for ARDS, which is associated with high morbidity and mortality. The mainstay of therapy in ARDS is supportive therapy and invasive mechanical ventilation based on lung-protective strategies using low tidal volume (VT) at 4-6 ml/kg of predicted body weight (PBW) and plateau pressure (p PLAT) below 30 cm H2O, but other adjunctive therapies have been trialed with various degrees of efficacy, including neuromuscular blockade, prone positioning, recruitment maneuvers (RMs), vasodilators, and extracorporeal membrane oxygenation (ECMO).
Hypertonic saline 3% NaCl with 513 mEq/L of Na and 513 mEq/L of Cl is a potent anti-inflammatory agent, and immunomodulator, which exerts inhibitory effects in several stages of the inflammatory cascade. Hypertonic saline, at a cellular level, decreases alveolar macrophage activation, polymorph nuclear leucocyte recruitment, priming and activation, as well as cell surface adhesion molecule expression. High plasma sodium contributes to high plasma osmolality which can be lung protective and would seem to be a logical choice for treatment of ARDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Patients will receive the standard pharmacotherapy of Acute Respiratory Distress Syndrome (ARDS) patients. | |
| Inhalational group | Experimental | Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr. |
|
| Intravenous group | Experimental | Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline 3% nebulizer | Drug | Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who will need mechanical ventilation | Number of patients who will need mechanical ventilation will be assessed. | 28 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay | Length of ICU stay will be measured from the admission till the discharge from the hospital. | 28 days after intervention |
| Lung injury score (Murray score) | Murray score (lung injury score) will be calculated daily in the morning based on information obtained from:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed E Elfakhrany, MBBCH | Contact | 00201023825321 | mohamed169729_pg@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Intravenous hypertonic saline 3% | Drug | Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L. |
|
| 24 hours after intervention |
| Incidence of mortality | Incidence of mortality will be assessed at 7th, and 28th day. | 28 days after intervention |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004864 | Equipment and Supplies |
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