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Diuretic Versus Placebo in Pulmonary Embolism

NCT ID: NCT02268903

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-13

Study Completion Date

2018-05-31

Brief Summary

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Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related to an acute right ventricular (RV) failure due to the increase in right ventricular afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in case of shock. However several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilatation and ischemia and left ventricular compression by RV dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of fluid expansion. In a preliminary study published by our group, we showed that diuretic treatment in the setting of PE with RV dilatation is safe and is associated with an increase in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients with oliguria. This may be related to the decrease of ventricular interdependence and enhancement of both LV and RV function.

The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in patients referred for acute PE with RV dilatation compared to placebo. The combination of urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it indicates the disappearance of pre-shock symptoms and is therefore associated with a lower event risk. Thus, it allows early discharge of the patients from the intensive care unit.

Detailed Description

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Conditions

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Pulmonary Embolism With Right Ventricle Enlargement

Keywords

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Pulmonary Embolism Right Ventricle failure Diuretics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diuretics

Group Type ACTIVE_COMPARATOR

Diuretics : Furosemide

Intervention Type DRUG

Furosemide 80mg in one single direct intra venous injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in one single direct intra venous injection

Interventions

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Diuretics : Furosemide

Furosemide 80mg in one single direct intra venous injection

Intervention Type DRUG

Placebo

Placebo in one single direct intra venous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc DUBOIS-RANDE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Luc DUBOIS-RANDE, PU-PH

Role: CONTACT

Phone: (0)1 49 81 36 02

Email: [email protected]

Romain GALLET, CCA

Role: CONTACT

Phone: (0)1 49 81 36 02

Email: [email protected]

Facility Contacts

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Jean-Luc DUBOIS-RANDE, PU-PH

Role: primary

Dalila SELMANE, CRA

Role: backup

References

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Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. Chest. 2002 Mar;121(3):877-905. doi: 10.1378/chest.121.3.877.

Reference Type BACKGROUND
PMID: 11888976 (View on PubMed)

Lee FA. Hemodynamics of the right ventricle in normal and disease states. Cardiol Clin. 1992 Feb;10(1):59-67.

Reference Type BACKGROUND
PMID: 1739960 (View on PubMed)

Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.

Reference Type BACKGROUND
PMID: 18757870 (View on PubMed)

Perlroth DJ, Sanders GD, Gould MK. Effectiveness and cost-effectiveness of thrombolysis in submassive pulmonary embolism. Arch Intern Med. 2007 Jan 8;167(1):74-80. doi: 10.1001/archinte.167.1.74.

Reference Type BACKGROUND
PMID: 17210881 (View on PubMed)

Goldhaber SZ, Haire WD, Feldstein ML, Miller M, Toltzis R, Smith JL, Taveira da Silva AM, Come PC, Lee RT, Parker JA, et al. Alteplase versus heparin in acute pulmonary embolism: randomised trial assessing right-ventricular function and pulmonary perfusion. Lancet. 1993 Feb 27;341(8844):507-11. doi: 10.1016/0140-6736(93)90274-k.

Reference Type BACKGROUND
PMID: 8094768 (View on PubMed)

Lim P, Delmas C, Sanchez O, Meneveau N, Rosario R, Bouvaist H, Bernard A, Mansourati J, Couturaud F, Sebbane M, Coste P, Rohel G, Tardy B, Biendel C, Lairez O, Ivanes F, Gallet R, Dubois-Rande JL, Fard D, Chatelier G, Simon T, Paul M, Natella PA, Layese R, Bastuji-Garin S. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):2-9. doi: 10.1093/ehjacc/zuab082.

Reference Type DERIVED
PMID: 34632490 (View on PubMed)

Gallet R, Meyer G, Ternacle J, Biendel C, Brunet A, Meneveau N, Rosario R, Couturaud F, Sebbane M, Lamblin N, Bouvaist H, Coste P, Maitre B, Bastuji-Garin S, Dubois-Rande JL, Lim P. Diuretic versus placebo in normotensive acute pulmonary embolism with right ventricular enlargement and injury: a double-blind randomised placebo controlled study. Protocol of the DiPER study. BMJ Open. 2015 May 22;5(5):e007466. doi: 10.1136/bmjopen-2014-007466.

Reference Type DERIVED
PMID: 26002690 (View on PubMed)

Other Identifiers

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AOM 130519

Identifier Type: -

Identifier Source: org_study_id