Article Text

Download PDFPDF

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
  1. Romain Gallet1,
  2. Guy Meyer2,
  3. Julien Ternacle1,
  4. Caroline Biendel3,
  5. Anne Brunet4,
  6. Nicolas Meneveau5,
  7. Roger Rosario6,
  8. Francis Couturaud7,
  9. Mustapha Sebbane8,
  10. Nicolas Lamblin9,
  11. Helene Bouvaist10,
  12. Pierre Coste11,
  13. Bernard Maitre12,
  14. Sylvie Bastuji-Garin13,
  15. Jean-Luc Dubois-Rande1,
  16. Pascal Lim1
  1. 1Department of Cardiology, Hopital Henri Mondor, Creteil, France
  2. 2Division of Respiratory and Intensive Care, Hopital Europeen Georges Pompidou, Paris, France
  3. 3Department of Cardiology, CHU Rangueil, Toulouse, France
  4. 4Department of Cardiology and Cardiac Imaging, CHU, Tours, France
  5. 5Department of Cardiology, CHRU, Besancon, France
  6. 6Department of Cardiology, Hopital Saint-Joseph, Marseille, France
  7. 7Respiratory Department, CHRU de la Cavale Blanche, Brest, France
  8. 8Emergency Department, CHRU Lapeyronie, Montpellier, France
  9. 9Department of Cardiology, CHRU, Lille, France
  10. 10Department of Cardiology, CHU, Grenoble, France
  11. 11Department of Cardiology, CHU, Bordeaux, France
  12. 12Department of Pneumology, Hopital Henri Mondor, Creteil, France
  13. 13Clinical Research Department, Hopital Henri Mondor, Creteil, France
  1. Correspondence to Dr Romain Gallet; romain.gallet{at}yahoo.fr

Abstract

Introduction In acute pulmonary embolism (PE), poor outcome is usually related to right ventricular (RV) failure due to the increase in RV afterload. Treatment of PE with RV failure without shock is controversial and usually relies on fluid expansion to increase RV preload. However, several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilation and ischaemia, and increase left ventricular compression by RV dilation. 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.

Methods and analysis The Diuretic versus placebo in Pulmonary Embolism with Right ventricular enlargement trial (DiPER) is a prospective, multicentre, randomised (1:1), double-blind, placebo controlled study assessing the superiority of furosemide as compared with placebo in normotensive patients with confirmed acute PE and RV dilation (diagnosed on echocardiography or CT of the chest) and positive brain natriuretic peptide result. The primary end point will be a combined clinical criterion derived from simplified Pulmonary Embolism Severity Index (PESI) score and evaluated at 24 h. It will include: (1) urine output >0.5 mL/kg/min for the past 24 h; (2) heart rate <110 bpm; (3) systolic blood pressure >100 mm Hg and (4) arterial oxyhaemoglobin level >90%. Thirty-day major cardiac events defined as death, cardiac arrest, mechanical ventilation, need for catecholamine and thrombolysis, will be evaluated as a secondary end point. Assuming an increase of 30% in the primary end point with furosemide and a β risk of 10%, 270 patients will be required.

Ethics and dissemination Ethical approval was received from the ethical committee of Ile de France (2014-001090-14). The findings of the trial will be disseminated through peer-reviewed journals, and national and international conference presentations.

Trial registration number NCT02268903.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.