High Versus Low Dose Nitroglycerin in Acute Pulmonary Edema

Status Enrolling by invitation

Clinical 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. The main questions it aims to answer is: - Time of resolution of high blood pressure, hypoxia, tacchypnea - Need for invasive mechanical ventilation, ICU admission

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06107465
Study type	Interventional
Source	Alexandria University
Contact
Status	Enrolling by invitation
Phase	Phase 2/Phase 3
Start date	November 10, 2023
Completion date	July 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed	`NCT02232841` - Electrical Impedance Imaging of Patients on Mechanical Ventilation	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Withdrawn	`NCT04537975` - C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19	N/A
Recruiting	`NCT05276219` - Optimized Treatment of Pulmonary Edema or Congestion	Phase 4
Withdrawn	`NCT04508933` - Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Recruiting	`NCT03728491` - Education and Training Competences in Thoracic Ultrasound	N/A
Not yet recruiting	`NCT05095974` - Predictors of Pulmonary Edema in Severe Preeclampsia
Recruiting	`NCT04115514` - Treatment of ARDS With Instilled T3	Phase 2
Withdrawn	`NCT01713595` - Safety Study of Inhaled Saline in Acute Lung Injury	Phase 1
Completed	`NCT01940328` - Measurements of Doppler Signals Noninvasively From the Lung in Congestive Heart Failure	N/A
Completed	`NCT00554580` - Continuous Positive Airway Pressure for Acute Pulmonary Edema	Phase 3
Withdrawn	`NCT03942055` - The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema
Active, not recruiting	`NCT03767803` - Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Recruiting	`NCT05662995` - Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia	N/A
Completed	`NCT00289276` - FAST (Fluid Accumulation Status Trial)	N/A
Recruiting	`NCT05636631` - Chest U/S in Differentiating Lung Congestion & Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
Not yet recruiting	`NCT05222711` - The Use of a Monitoring Device by General Practitioners During Out-of-hours Care	N/A
Recruiting	`NCT02753023` - Registry Of Acute meDical Emergencies in Brazil
Recruiting	`NCT01269177` - Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.