Pulmonary EdemaPhase 2/3NCT06107465
High Versus Low Dose Nitroglycerin in Acute Pulmonary Edema
A Phase 2/3 study testing Nitroglycerin in people with Pulmonary Edema, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- Nitroglycerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2023to Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (> 18 years) presented with sympathetic crashing acute pulmonary edema.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Edema
- Being tested
- Nitroglycerin
- Keywords
- nitroglycein, dose, pulmonary edema
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
high dose Nitroglycerin
| Study group | Role | What they receive |
|---|---|---|
| High dose Nitroglycerin | Active comparator | Initial dose of >100 mic/min will be initiated Receives: Drug: Nitroglycerin |
| Low dose Nitroglycerin | Active comparator | Initial dose < 100 mic /min will be started Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of symptoms
( hypoxia, high blood pressure and tacchypnea )
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start10 Nov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelrahman Hemeda, Resident, Principal investigator, Alexandria University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107465
- Sponsor's protocol ID
- 0108016
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Dose Nitroglycerin in Management of Sympathetic Crashing Acute Pulmonary Edema
- ClinicalTrials.gov ID
- NCT06107465
- Acronym / sponsor ID
- 0108016
- Conditions
- Pulmonary Edema
- Keywords
- nitroglycein, dose, pulmonary edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Nitroglycerin | Active comparator | Drug: NitroglycerinInitial dose of >100 mic/min will be initiated |
| Low dose Nitroglycerin | Active comparator | Drug: NitroglycerinInitial dose < 100 mic /min will be started |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (> 18 years) presented with sympathetic crashing acute pulmonary edema.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerinhigh dose Nitroglycerin | Drug | High dose Nitroglycerin, Low dose Nitroglycerin |
Primary outcome
Resolution of symptoms
Time frame: approximately 6 months
( hypoxia, high blood pressure and tacchypnea )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrahman Hemeda, Resident principal investigator
Alexandria University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nitroglycerin in people with Pulmonary Edema, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of symptoms (time frame: approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.