Epilepsia Open (Sep 2022)
KETASER01 protocol: What went right and what went wrong
- Anna Rosati,
- Manuela L’Erario,
- Roberto Bianchi,
- Sara Olivotto,
- Domenica Immacolata Battaglia,
- Francesca Darra,
- Paolo Biban,
- Annibale Biggeri,
- Dolores Catelan,
- Giacomo Danieli,
- Maria Cristina Mondardini,
- Duccio Maria Cordelli,
- Angela Amigoni,
- Elisabetta Cesaroni,
- Alessandra Conio,
- Paola Costa,
- Martina Lombardini,
- Rosanna Meleleo,
- Alessandra Pugi,
- Elena Eve Tornaboni,
- Marta Elena Santarone,
- Roberta Vittorini,
- Stefano Sartori,
- Carla Marini,
- Federico Vigevano,
- Massimo Mastrangelo,
- Silvia Maria Pulitanò,
- Francesca Izzo,
- Lucia Fusco
Affiliations
- Anna Rosati
- Neuroscience Department Meyer Children’s Hospital‐University of Florence Florence Italy
- Manuela L’Erario
- Intensive Care Unit Meyer Children’s Hospital‐University of Florence Florence Italy
- Roberto Bianchi
- Intensive Care Unit Bambino Gesù Children’s Hospital, IRCCS Rome Italy
- Sara Olivotto
- Pediatric Neurology Unit Children’s Hospital Vittore Buzzi, ASST Fatebenefratelli Sacco Milan Italy
- Domenica Immacolata Battaglia
- Department of Child Neurology and Psychiatry Catholic University Rome Italy
- Francesca Darra
- Child Neuropsychiatry Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics University of Verona Verona Italy
- Paolo Biban
- Department of Neonatal and Pediatric Intensive Care University Hospital Verona Italy
- Annibale Biggeri
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua Padua Italy
- Dolores Catelan
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua Padua Italy
- Giacomo Danieli
- Department of Statistics, Computer Science, Applications G. Parenti University of Florence Florence Italy
- Maria Cristina Mondardini
- Department of Pediatric Anesthesia and Intensive Care Sant’Orsola‐Malpighi Hospital, University of Bologna Bologna Italy
- Duccio Maria Cordelli
- IRCCS Institute of Neurological Sciences of Bologna UOC Neuropsychiatry of the Pediatric Age Bologna Italy
- Angela Amigoni
- Intensive Care Unit, Department of Woman’s and Child’s Health University Hospital of Padua Padua Italy
- Elisabetta Cesaroni
- Child Neuropsychiatry Unit Polytechnic University of the Marche Ancona Italy
- Alessandra Conio
- Pediatric Intensive Care Unit Health and Science City Hospital‐University of Turin Turin Italy
- Paola Costa
- Department of Neuropsychiatry Ward Institute for Maternal and Child Health, IRCCS “Burlo Garofolo” Trieste Italy
- Martina Lombardini
- Neuroscience Department Meyer Children’s Hospital‐University of Florence Florence Italy
- Rosanna Meleleo
- Intensive Care Unit Institute for Maternal and Child Health, IRCCS “Burlo Garofolo” Trieste Italy
- Alessandra Pugi
- Clinical Trial Office Meyer Children’s Hospital‐University of Florence Florence Italy
- Elena Eve Tornaboni
- Clinical Trial Office Meyer Children’s Hospital‐University of Florence Florence Italy
- Marta Elena Santarone
- Department of Neuroscience Bambino Gesù Children’s Hospital, IRCCS, Full Member of European Reference Network EpiCARE Rome Italy
- Roberta Vittorini
- Child and Adolescence Neuropsychiatry Unit Health and Science City Hospital‐University of Turin Turin Italy
- Stefano Sartori
- Pediatric Neurology Unit, Department of Woman’s and Child’s Health University Hospital of Padua Padua Italy
- Carla Marini
- Child Neuropsychiatry Unit Polytechnic University of the Marche Ancona Italy
- Federico Vigevano
- Department of Neuroscience Bambino Gesù Children’s Hospital, IRCCS, Full Member of European Reference Network EpiCARE Rome Italy
- Massimo Mastrangelo
- Pediatric Neurology Unit Children’s Hospital Vittore Buzzi, ASST Fatebenefratelli Sacco Milan Italy
- Silvia Maria Pulitanò
- Intensive Care Unit Catholic University Rome Italy
- Francesca Izzo
- Pediatric Intensive Care Unit Children’s Hospital Vittore Buzzi, ASST Fatebenefratelli Sacco Milan Italy
- Lucia Fusco
- Department of Neuroscience Bambino Gesù Children’s Hospital, IRCCS, Full Member of European Reference Network EpiCARE Rome Italy
- DOI
- https://doi.org/10.1002/epi4.12627
- Journal volume & issue
-
Vol. 7,
no. 3
pp. 532 – 540
Abstract
Abstract Objective To discuss the results of the KETASER01 trial and the reasons for its failure, particularly in view of future studies. Methods KETASER01 is a multicenter, randomized, controlled, open‐label, sequentially designed, non‐profit Italian study that aimed to assess the efficacy of ketamine compared with conventional anesthetics in the treatment of refractory convulsive status epilepticus (RCSE) in children. Results During the 5‐year recruitment phase, a total of 76 RCSEs treated with third‐line therapy were observed in five of the 10 participating Centers; only 10 individuals (five for each study arm; five females, mean age 6.5 ± 6.3 years) were enrolled in the KETASER01 study. Two of the five patients (40%) in the experimental arm were successfully treated with ketamine and two of the five (40%) children in the control arm, where successfully treated with thiopental. In the remaining six (60%) enrolled patients, RCSE was not controlled by the randomized anesthetic(s). Significance The KETASER01 study was prematurely halted due to low eligibility of patients and no successful recruitment. No conclusions can be drawn regarding the objectives of the study. Here, we discuss the KETASER01 results and critically analyze the reasons for its failure in view of future trials.
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