High Versus Low Dose Nitroglycerin in Acute Pulmonary Edema

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Edema
• Intervention / Treatment: Drug: Nitroglycerin

Detailed Description

This single blind parallel randomized controlled trial will be conducted on (30 patients in each group) presented to Alexandria University Hospitals with acute pulmonary edema defined as: acute onset of dyspnea < 6 hrs, tacchypnea ( respiratory rate ≥30 breaths/min), bilaterak crepitations, O2 saturation < 90% on room air with associted sympathetic surge recognized by presence of tacchycardia, agitationa and blood pressure ≥ 160/90 mmHg

All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:

• Group (A): Low dose group Nitroglycerin at will be initiated at a rate <100 mic/min (15)
• Group (B): high dose group Initial dose > 100 mic /min (15) will be started Blood pressure will be measured for both groups every 15 minutes and dose adjusted accordingly, if the blood pressure starts to decrease continue infusion rate. In case of rising or constant blood pressure increase nitroglycerin by 20 mic/min every 15 min till blood pressure starts to decrease.

Initial, peak rate within the first hour, duration of IV nitroglycerin infusion will be recorded in both groups.

Initial and maximum dose of loop diuretic will be recorded in both groups.

Outcome:

Patients will be followed during ED stay to compare the two groups as regard:

• Time of resolution of high blood pressure.
• Resolution of hypoxia.
• Resolution of tachypnea.
• Need for invasive mechanical ventilation.
• Need for ICU admission.
• Length of hospital stay.
• Incidence of drug side effects as hypotension.
• Mortality.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria university, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High dose Nitroglycerin; Initial dose of >100 mic/min will be initiated	Drug: Nitroglycerin; high dose Nitroglycerin
Active Comparator: Low dose Nitroglycerin; Initial dose < 100 mic /min will be started	Drug: Nitroglycerin; high dose Nitroglycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of symptoms	( hypoxia, high blood pressure and tacchypnea )	approximately 6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Abdelrahman Hemeda, Resident, Alexandria university, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: dose; pulmonary edema; nitroglycein
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 0108016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No