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

NCT06226402 | Unknown

• 1 other identifier: 36264MS225/6/23
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Nebulization; Hypertonic Saline; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of patients who will need mechanical ventilation

  Number of patients who will need mechanical ventilation will be assessed.

  28 days after intervention

Secondary Outcomes (3)

• Length of ICU stay

  28 days after intervention

• Lung injury score (Murray score)

  24 hours after intervention

• Incidence of mortality

  28 days after intervention

Study Arms (3)

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.

Drug: Hypertonic saline 3% nebulizer

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.

Drug: Intravenous hypertonic saline 3%

Interventions

Hypertonic saline 3% nebulizer DRUG

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

Inhalational group

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.

Intravenous group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Saline Solution, Hypertonic; Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Equipment and Supplies

Central Study Contacts

Mohamed E Elfakhrany, MBBCH

CONTACT

00201023825321; mohamed169729_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)