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

T

Tanta University

Status

Enrolling

Conditions

Hypertonic Saline
Acute Respiratory Distress Syndrome
Nebulization

Treatments

Drug: Intravenous hypertonic saline 3%
Drug: Hypertonic saline 3% nebulizer

Study type

Interventional

Funder types

Other

Identifiers

NCT06226402
36264MS225/6/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 3 patient groups

Control group
No Intervention group
Description:
Patients will receive the standard pharmacotherapy of Acute Respiratory Distress Syndrome (ARDS) patients.
Inhalational group
Experimental group
Description:
Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.
Treatment:
Drug: Hypertonic saline 3% nebulizer
Intravenous group
Experimental group
Description:
Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.
Treatment:
Drug: Intravenous hypertonic saline 3%

Trial contacts and locations

1

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Central trial contact

Mohamed E Elfakhrany, MBBCH

Data sourced from clinicaltrials.gov

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