Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome

Not Applicable

Recruiting

• Conditions: Nebulization; Hypertonic Saline; Acute Respiratory Distress Syndrome
• Interventions: Drug: Hypertonic saline 3% nebulizer; Drug: Intravenous hypertonic saline 3%

• Registration Number: NCT06226402
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Age from 21 to 60 years old.
• Both sexes.
• Patients with mild and moderate ARDS whose PaO2/FiO2 ratio ≥ 150 according to the Berlin definition of Acute Respiratory Distress Syndrome.

Exclusion Criteria

• Refusal to participate in the study.
• Malignancy.
• Patients on chemotherapy.
• Decompensated renal, hepatic and cardiac disease.
• Patients with hypernatremia whose serum Na above 155 mEq/L.
• Patients with ARDS whose PaO2/FiO2 ratio > 150.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalational group	Hypertonic saline 3% nebulizer	Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.
Intravenous group	Intravenous hypertonic saline 3%	Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.

Primary Outcome Measures

Name	Time	Method
Number of patients who will need mechanical ventilation	28 days after intervention	Number of patients who will need mechanical ventilation will be assessed.

Secondary Outcome Measures

Name	Time	Method
Lung injury score (Murray score)	24 hours after intervention	Murray score (lung injury score) will be calculated daily in the morning based on information obtained from: 1. Number of quadrants of infiltrations from chest X-ray.; 2. Hypoxic index.; 3. Positive end expiratory pressure (PEEP) required on the ventilator to get better oxygenation.; 4. Static compliance.
Length of ICU stay	28 days after intervention	Length of ICU stay will be measured from the admission till the discharge from the hospital.
Incidence of mortality	28 days after intervention	Incidence of mortality will be assessed at 7th, and 28th day.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt