NCT06107465

Brief Summary

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Pulmonary Edema

Keywords

nitroglyceindosepulmonary edema

Outcome Measures

Primary Outcomes (1)

  • Resolution of symptoms

    ( hypoxia, high blood pressure and tacchypnea )

    approximately 6 months

Study Arms (2)

High dose Nitroglycerin

ACTIVE COMPARATOR

Initial dose of \>100 mic/min will be initiated

Drug: Nitroglycerin

Low dose Nitroglycerin

ACTIVE COMPARATOR

Initial dose \< 100 mic /min will be started

Drug: Nitroglycerin

Interventions

NitroglycerinDRUG

high dose Nitroglycerin

High dose NitroglycerinLow dose Nitroglycerin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients (\> 18 years) presented with sympathetic crashing acute pulmonary edema.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Abdelrahman Hemeda, Resident

    Alexandria University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 30, 2023

Study Start

November 10, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

EG(1)