Limits...
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.

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 - BMJ Open (2015)

Bottom Line: By reducing RV enlargement, diuretic treatment may break this vicious circle and provide early improvement in normotensive patients referred for acute PE with RV failure.Assuming an increase of 30% in the primary end point with furosemide and a β risk of 10%, 270 patients will be required.Ethical approval was received from the ethical committee of Ile de France (2014-001090-14).

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Hopital Henri Mondor, Creteil, France.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of the DiPER trial. DiPER, Diuretic versus placebo in Pulmonary Embolism with Right ventricular enlargement; PE, pulmonary embolism; BNP, brain natriuretic peptide; RV, right ventricle; SAE, serious adverse events.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4442189&req=5

BMJOPEN2014007466F1: Flow diagram of the DiPER trial. DiPER, Diuretic versus placebo in Pulmonary Embolism with Right ventricular enlargement; PE, pulmonary embolism; BNP, brain natriuretic peptide; RV, right ventricle; SAE, serious adverse events.

Mentions: The study flow diagram is displayed in figure 1. After randomisation, a number corresponding to a single-dose vial containing the study drug or placebo will be assigned to the patient. Each vial will contain either furosemide 80 mg or placebo. Only the treatment number will be mentioned on the vial, so patients, investigators and anyone involved in care or in data analysis will be blinded to the treatment. Treatment will be administrated by a single intravenous injection (bolus injection) immediately after randomisation. Patients and investigators will both be blind regarding study treatment. The anticoagulant regimen will consist of unfractionated heparin, low molecular weight heparin or fondaparinux, according to local practice. Fluid expansion will be authorised if judged necessary, but will be recorded. Oxygen administration will be decided by the investigator and will be recorded. As per guidelines, thrombolytic treatment will not be allowed until clinical signs of shock, cardiac arrest or sustained hypotension occur. The dose of 80 mg for furosemide treatment was derived from the preliminary study, in which patients received 78±42 mg furosemide. We have demonstrated safety and potential efficacy with the dosage, therefore we chose it for the randomised study.


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.

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 - BMJ Open (2015)

Flow diagram of the DiPER trial. DiPER, Diuretic versus placebo in Pulmonary Embolism with Right ventricular enlargement; PE, pulmonary embolism; BNP, brain natriuretic peptide; RV, right ventricle; SAE, serious adverse events.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4442189&req=5

BMJOPEN2014007466F1: Flow diagram of the DiPER trial. DiPER, Diuretic versus placebo in Pulmonary Embolism with Right ventricular enlargement; PE, pulmonary embolism; BNP, brain natriuretic peptide; RV, right ventricle; SAE, serious adverse events.
Mentions: The study flow diagram is displayed in figure 1. After randomisation, a number corresponding to a single-dose vial containing the study drug or placebo will be assigned to the patient. Each vial will contain either furosemide 80 mg or placebo. Only the treatment number will be mentioned on the vial, so patients, investigators and anyone involved in care or in data analysis will be blinded to the treatment. Treatment will be administrated by a single intravenous injection (bolus injection) immediately after randomisation. Patients and investigators will both be blind regarding study treatment. The anticoagulant regimen will consist of unfractionated heparin, low molecular weight heparin or fondaparinux, according to local practice. Fluid expansion will be authorised if judged necessary, but will be recorded. Oxygen administration will be decided by the investigator and will be recorded. As per guidelines, thrombolytic treatment will not be allowed until clinical signs of shock, cardiac arrest or sustained hypotension occur. The dose of 80 mg for furosemide treatment was derived from the preliminary study, in which patients received 78±42 mg furosemide. We have demonstrated safety and potential efficacy with the dosage, therefore we chose it for the randomised study.

Bottom Line: By reducing RV enlargement, diuretic treatment may break this vicious circle and provide early improvement in normotensive patients referred for acute PE with RV failure.Assuming an increase of 30% in the primary end point with furosemide and a β risk of 10%, 270 patients will be required.Ethical approval was received from the ethical committee of Ile de France (2014-001090-14).

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Hopital Henri Mondor, Creteil, France.

No MeSH data available.


Related in: MedlinePlus