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.

Rosati, A., L'Erario, M., Bianchi, R., Olivotto, S., Battaglia, D.I., Darra, F., et al. (2022). KETASER01 protocol: What went right and what went wrong. EPILEPSIA OPEN, 7(3), 532-540 [10.1002/epi4.12627].

KETASER01 protocol: What went right and what went wrong

Cordelli, Duccio Maria;Mastrangelo, Massimo;
2022

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.
2022
Rosati, A., L'Erario, M., Bianchi, R., Olivotto, S., Battaglia, D.I., Darra, F., et al. (2022). KETASER01 protocol: What went right and what went wrong. EPILEPSIA OPEN, 7(3), 532-540 [10.1002/epi4.12627].
Rosati, Anna; L'Erario, Manuela; Bianchi, Roberto; Olivotto, Sara; Battaglia, Domenica Immacolata; Darra, Francesca; Biban, Paolo; Biggeri, Annibale; ...espandi
File in questo prodotto:
File Dimensione Formato  
EPI4-7-532.pdf

accesso aperto

Tipo: Versione (PDF) editoriale
Licenza: Licenza per Accesso Aperto. Creative Commons Attribuzione (CCBY)
Dimensione 273.13 kB
Formato Adobe PDF
273.13 kB Adobe PDF Visualizza/Apri
EPI4-7-532-s002.doc

accesso aperto

Tipo: File Supplementare
Licenza: Licenza per Accesso Aperto. Creative Commons Attribuzione (CCBY)
Dimensione 36.5 kB
Formato Microsoft Word
36.5 kB Microsoft Word Visualizza/Apri
EPI4-7-532-s001.docx

accesso aperto

Tipo: File Supplementare
Licenza: Licenza per Accesso Aperto. Creative Commons Attribuzione (CCBY)
Dimensione 74.64 kB
Formato Microsoft Word XML
74.64 kB Microsoft Word XML Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/901447
Citazioni
  • ???jsp.display-item.citation.pmc??? 3
  • Scopus 9
  • ???jsp.display-item.citation.isi??? 4
social impact