SYF2277ae0c12ef460f9f90848918d638bfRegistry ID: 2024-515934-34-00|RecruitingPhase 4
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interventional
N/A
1 country
35
To assess the effect of administering landiolol as cardioplegia adjuvant to reduce the occurrence of postoperative low-cardiac output syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2024
Actual (reported)The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:
need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);
need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);
need for renal replacement therapy at any time during the intensive care unit stay.
Patients requiring prolonged (>48 h) catecholamine infusion;
patients with increased postoperative cardiac biomarkers (Troponin I or T);
patients with a reduction in left ventricular ejection fraction;
number of patients readmitted to hospital for cardiac reasons;
EQ-5D-5L questionnaire;
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universita' Campus Bio-medico Di Roma
Rome, 00128, Italy
Azienda Ospedaliero-Universitaria Sant Andre
Rome, 00189, Italy
Azienda Socio Sanitaria Territoriale Ovest Milanese
Legnano, 20025, Italy
Fabrizio Monaco
First Submitted
July 22, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia
Contact the study team to confirm eligibility.
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123, Italy
Mater Dei Hospital
Maddaloni, Caserta, 20100, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95123, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
San Camillo Forlanini Hospital
Rome, 00152, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, 10126, Italy
Casa Di Cura San Michele Srl
Maddaloni, Caserta, 20100, Italy
Universita' Degli Studi Di Verona
Verona, 37126, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, 16132, Italy
Azienda Ospedaliero Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliera Santa Croce E Carle
Cuneo, 12100, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, 71122, Italy
Ospedale Vito Fazzi Lecce
Lecce, 73100, Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Salerno, 84131, Italy
Fondazione Toscana Gabriele Monasterio
Massa, 54100, Italy
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Alexandria, 15121, Italy
Alessandro Manzoni Hospital
Lecco, 23900, Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica
Vicenza, 36100, Italy
Policlinico San Donato S.p.A.
San Donato Milanese, 20097, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliera Regionale San Carlo
Potenza, 85100, Italy
Maria Cecilia Hospital S.p.A.
Cotignola, 48033, Italy
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Varese, 21100, Italy
Humanitas Mirasole S.p.A.
Rozzano, 20089, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, 10128, Italy
Centro Cardiologico Monzino S.p.A.
Milan, 20138, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Rome, 00133, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100, Italy