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

NCT ID: NCT06226402

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-01

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.

Conditions

Nebulization; Hypertonic Saline; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients will receive the standard pharmacotherapy of Acute Respiratory Distress Syndrome (ARDS) patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Inhalational group

Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.

Group Type: EXPERIMENTAL

Hypertonic saline 3% nebulizer

Intervention Type: DRUG

Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.

Intravenous group

Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.

Group Type: EXPERIMENTAL

Intravenous hypertonic saline 3%

Intervention Type: DRUG

Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.

Interventions

Hypertonic saline 3% nebulizer

Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elsayed Mohamed Elfakhrany

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed E Elfakhrany, MBBCH

Role: CONTACT

mohamed169729_pg@med.tanta.edu.eg

00201023825321

Facility Contacts

Mohamed E Elfakhrany, MBBCH

Role: primary

mohamed169729_pg@med.tanta.edu.eg

00201023825321

Other Identifiers

36264MS225/6/23

Identifier Type: -

Identifier Source: org_study_id