Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT02268903
Eligibility Criteria:
Inclusion Criteria:
Patients aged 18 years and over with
1. Symptomatic acute pulmonary embolism with first clinical symptoms within 15 days, and objectively confirmed by CT scan
2. RV dysfunction (≥1 criterion) confirmed by elevated BNP value or echocardiography or spiral computed tomography of the chest:
* Echocardiography
o Right/Left ventricular end diastolic diameter \> 1(apical or subcostal 4-chamber view)
* Computed tomography
o Right/Left short-axis diameter ratio\>0.9 (transverse plane)
* Positive Nt-proBNP (\>600) or BNP\>200 pg/mL
3. One abnormal following PESI criteria
* Heart Rate\>110/min
* Systolic blood pressure\<100mmHg
* Arterial oxyhemoglobin level\<90% on room air or after 5 minutes of oxygen withdrawal.
Exclusion Criteria:
* Cardiogenic shock requiring thrombolysis
* Previous significant left ventricular insufficiency (LVEF\<45%)
* Systolic blood pressure\<90mmHg at admission
* Age ≤ 18 years
* Pregnancy
* No health insurance
* Patients deprived of liberty or under legal protection
* Creatinin clearance \<30mL/min/m²
* hypersensibility to furosemide or its excipients
* functional renal insufficiency
* Hepatic encephalopathy
* Urinary tracks obstruction
* Hypovolemia or dehydration.
* Sever hypokalemia (K+ \< 3mmol/L)
* Severe hyponatremia (Na+ \< 125mmol/L)
* Ongoing hepatitis and hepatic insufficiency severe in patients with renal insufficiency or dialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02268903
Study Brief:
Protocol Section:
NCT02268903