Dataset Information

KETASER01 protocol: What went right and what went wrong.

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.

SUBMITTER: Rosati A

PROVIDER: S-EPMC9436287 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

KETASER01 protocol: What went right and what went wrong.

Rosati Anna A L'Erario Manuela M Bianchi Roberto R Olivotto Sara S Battaglia Domenica Immacolata DI Darra Francesca F Biban Paolo P Biggeri Annibale A Catelan Dolores D Danieli Giacomo G Mondardini Maria Cristina MC Cordelli Duccio Maria DM Amigoni Angela A Cesaroni Elisabetta E Conio Alessandra A Costa Paola P Lombardini Martina M Meleleo Rosanna R Pugi Alessandra A Tornaboni Elena Eve EE Santarone Marta Elena ME Vittorini Roberta R Sartori Stefano S Marini Carla C Vigevano Federico F Mastrangelo Massimo M Pulitanò Silvia Maria SM Izzo Francesca F Fusco Lucia L

Epilepsia open 20220725 3

<h4>Objective</h4>To discuss the results of the KETASER01 trial and the reasons for its failure, particularly in view of future studies.<h4>Methods</h4>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.<h4>Results</h4>During the 5-year recruitment phase, a total of 76 RCSE ...[more]

PMID: 35833327

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Dataset Information

KETASER01 protocol: What went right and what went wrong.

Objective

Methods

Results

Significance

Publications

KETASER01 protocol: What went right and what went wrong.

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