Clinical trial

High Versus Low Dose Nitroglycerin in Management of Sympathetic Crashing Acute Pulmonary Edema

Name

0108016

Description

The goal of this randomized controlled trial is evaluate the out come of: * Low dose (\< 100 mic/min )versus * High dose (\> 100 mic/min) of nitroglycerin in management of patients with acute pulmonary edema presented to Emergency Department of Alexandria University Hospitals. The main questions it aims to answer is: * Time of resolution of high blood pressure, hypoxia, tacchypnea * Need for invasive mechanical ventilation, ICU admission

Trial arms

Trial start

2023-11-10

Estimated PCD

2024-06-01

Trial end

2024-07-01

Phase

Early phase I

Treatment

Nitroglycerin

high dose Nitroglycerin

Arms:

High dose Nitroglycerin, Low dose Nitroglycerin

Size

Primary endpoint

Resolution of symptoms

approximately 6 months

Eligibility criteria

Inclusion Criteria: * All adult patients (\> 18 years) presented with sympathetic crashing acute pulmonary edema. Exclusion Criteria: 1 - Patients indicated for emergency endotracheal intubation. 2-Patients with history of nitroglycerin allergy. 3-Preload dependent patients as patients with aortic stenosis. 4-Drug interaction with nitroglycerin as sildenafil, ergots. 5-Patients indicated for emergency percutaneous intervention.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-30

1 organization

1 product

1 indication

Organization

Alexandria University

Product

Nitroglycerin

Indication

Pulmonary Edema