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

January 17, 2024 updated by: Mohamed Elsayed Mohamed Elfakhrany, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Recruiting
        • Tanta University
        • Contact:
        • Sub-Investigator:
          • Sabry M Ameen, MD
        • Sub-Investigator:
          • Jehan M Darwish, MD
        • Sub-Investigator:
          • Taysser M Abdalraheem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients will receive the standard pharmacotherapy of Acute Respiratory Distress Syndrome (ARDS) patients.
Experimental: Inhalational group
Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.
Drug: Hypertonic saline 3% nebulizer
Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who will need mechanical ventilation
Time Frame: 28 days after intervention
Number of patients who will need mechanical ventilation will be assessed.
28 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: 28 days after intervention
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)
Time Frame: 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.
24 hours after intervention
Incidence of mortality
Time Frame: 28 days after intervention
Incidence of mortality will be assessed at 7th, and 28th day.
28 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264MS225/6/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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