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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00554580 |
We hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improve the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Edema Dyspnea Paroxysmal Congestive Heart Failure |
Procedure: Continuous Positive Airway Pressure (CPAP) Procedure: usual care of acute pulmonary oedema |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema |
Estimated Enrollment: | 400 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Usual care of pulmonary acute oedema
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Procedure: usual care of acute pulmonary oedema
Usual treatment of acute pulmonary oedema including : Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg. Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes. As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of 5 à 20 µg/kg/min. |
B: Experimental
CPAP + usual care of pulmonary acute oedema
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Procedure: Continuous Positive Airway Pressure (CPAP)
Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy: stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status. |
Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: DUCROS Laurent, MD Phd | +33(1) 49 95 61 61 | laurent.ducros@lrb.aphp.fr |
France | |
DUCROS Laurent | Recruiting |
Paris, France, 75010 | |
Contact: DUCROS Laurent, MD PhD | |
Hôpital Lariboisière - Cardiologie | Recruiting |
Paris, France, 75010 | |
Contact: HENRY Patrick, Pr 33-1 49.95.82.24 | |
Principal Investigator: HENRY Patrick, Pr | |
Hopital Pitié Salpétrière-DAR-SMUR | Recruiting |
Paris, France, 75013 | |
Contact: ECOLLAN Patrick, Pr 33-1 42 16 22 53 | |
Hopital Beaujon-DAR-SMUR | Recruiting |
Clichy, France, 92110 | |
Contact: BELPOMME Vanessa, Pr 33-1 40 87 59 13 | |
Hopital Beaujon-Cardiologie | Recruiting |
Clichy, France, 92110 | |
Contact: LOGEART Damien, Dr 33-1 40 8758 92 | |
Hopital Necker-SAMU75-SMUR | Recruiting |
Paris, France, 75015 | |
Contact: JANNIERE Daniel, Pr 33-1 44 49 24 73 | |
Hopital Europeen Georges Pompidou-Cardiologie | Recruiting |
Paris, France, 75015 | |
Contact: BENSOUDA Christophe, Pr 33-1 56 09 28 51 | |
Chu- Samu 29 | Recruiting |
Brest, France, 29200 | |
Contact: VERGNE Muriel, Dr 33-2 98 34 79 00 | |
CHU Brest- UHCD | Recruiting |
Brest, France, 29200 | |
Contact: L'HER Erwan, Pr 33-2 98 34 71 81 | |
CHU Brest-Cardiologie | Recruiting |
Brest, France, 29200 | |
Contact: BLANC Jean Jaques, Pr 33-2 98 34 71 86 | |
Hopital Foch- Cardiologie | Recruiting |
Suresnes, France, 92 | |
Contact: HAZIZA Franck, Dr 33-1 46 25 24 68 | |
CHR6Cardiologie | Recruiting |
Orleans La Source, France, 45100 | |
Contact: DIBON Olivier 33-2 38 51 48 04 | |
Clinique de la Reine Blanche-Cardiologie | Recruiting |
Orleans, France, 45100 | |
Contact: PLACENTE Marius, Dr 33-2 38 79 83 83 | |
CH Delafontaine-SMUR | Recruiting |
Saint Denis, France, 93 | |
Contact: HENNEQUIN Brigitte 33-1 42 35 61 40 | |
CH Delafontaune-Réanimation médicale | Recruiting |
Saint Denis, France, 93 | |
Contact: ADRIE Christophe 33-1 42 35 61 40 Bip 046 | |
Hopital Simone Veil-SMUR | Recruiting |
Eaubonne, France, 95600 | |
Contact: EL SAYED KAMEL Mohamed, Pr 33-6 63 54 73 54 | |
CH-SMUR | Recruiting |
Montfermeil, France, 93370 | |
Contact: CAVAGNA Patrick, Dr 33-1 41 70 80 00 | |
CH-Cardiologie | Recruiting |
Montfermeil, France, 93370 | |
Contact: NALLET Olivier, Dr 33-1 41 70 81 01 | |
Contact: MICHAUD Pierre, Dr 33-1 41 70 81 01 | |
CH-Urgences-SMUR | Recruiting |
Beziers, France, 34543 | |
Contact: FREDERIQUE Charles, Dr 33-4 67 35 70 96 | |
Hopital Simone Veil-Cardiologie | Recruiting |
Eaubonne, France, 95600 | |
Contact: GHANEM Nachwan, Dr 33-1 34 06 60 00 Bip 7278 | |
CHR-SAMU 45 | Recruiting |
Orleans La Source, France, 45100 | |
Contact: LAGARDE Sophie, Dr 33-2 38 66 85 26 |
Principal Investigator: | DUCROS Laurent, MD PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | delegation clinical research of the developpement ( Myriem TOUHAMI-CARRIER ) |
Study ID Numbers: | P 030428, AOM 03073 |
Study First Received: | November 6, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00554580 |
Health Authority: | France: Ministry of Health |
continuous positive airway pressure outcome measure clinical trial |
Isosorbide Heart Failure Heart Diseases Isosorbide-5-mononitrate Edema Isosorbide Dinitrate Furosemide |
Dobutamine Signs and Symptoms Pulmonary Edema Respiratory Tract Diseases Lung Diseases Dyspnea |
Cardiovascular Diseases |