Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
Overview
- Phase
- Phase 3
- Intervention
- Oxygen gas
- Conditions
- Pulmonary Embolism
- Sponsor
- Ministry of Health, Spain
- Enrollment
- 70
- Locations
- 7
- Primary Endpoint
- Normal right ventricle function at 48 hours
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
Investigators
David Jimenez
Pulmonary physician
Ministry of Health, Spain
Eligibility Criteria
Inclusion Criteria
- •Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
- •Disfunction of right ventricle (RV to left ventricle \[LV\] diameter ratio \>1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
- •Signed and dated informed consent of the subject.
Exclusion Criteria
- •\<18 years old.
- •Allergy to iodinated contrast.
- •Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
- •Use of chronic oxygen therapy.
- •Hypercapnia (pCO2 \>50 mmHg at the time of diagnosis).
- •Technically inadequate basal echocardiography.
- •Contraindication to anticoagulant therapy.
- •Symptoms duration \>10 days.
- •Haemodynamic instability.
- •Participation in other clinical trial for PE treatment during the present clinical trial.
Arms & Interventions
Supplementary oxygen
Supplementary oxygen added to conventional anticoagulant treatment.
Intervention: Oxygen gas
Outcomes
Primary Outcomes
Normal right ventricle function at 48 hours
Time Frame: 48 hours
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
Secondary Outcomes
- Modification RV -LV 7 days(7 days)