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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06226402
Other study ID # 36264MS225/6/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2024

Study information

Verified date January 2024
Source Tanta University
Contact Mohamed E Elfakhrany, MBBCH
Phone 00201023825321
Email mohamed169729_pg@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who will need mechanical ventilation Number of patients who will need mechanical ventilation will be assessed. 28 days after intervention
Secondary Length of ICU stay Length of ICU stay will be measured from the admission till the discharge from the hospital. 28 days after intervention
Secondary Lung injury score (Murray score) Murray score (lung injury score) will be calculated daily in the morning based on information obtained from:
Number of quadrants of infiltrations from chest X-ray.
Hypoxic index.
Positive end expiratory pressure (PEEP) required on the ventilator to get better oxygenation.
Static compliance.
24 hours after intervention
Secondary Incidence of mortality Incidence of mortality will be assessed at 7th, and 28th day. 28 days after intervention
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