Clinical trial
Comparative Study Between the Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome
Name
36264MS225/6/23
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Treatment
Hypertonic saline 3% nebulizer
Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.
Arms:
Inhalational group
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.
Arms:
Intravenous group
Size
105
Primary endpoint
Number of patients who will need mechanical ventilation
28 days after intervention
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 105, 'type': 'ESTIMATED'}}
Updated at
2024-01-26
1 organization
2 products
3 indications
Organization
Tanta UniversityProduct
Hypertonic saline 3%Indication
Inhalation TherapyIndication
Hypertonic SalineIndication
Acute Respiratory Distress Syndrome