• Something wrong with this record ?

The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial

A. Neubert, MA. Baarslag, MV. Dijk, JV. Rosmalen, JF. Standing, Y. Sheng, W. Rascher, D. Roberts, J. Winslade, L. Rawcliffe, SM. Hanning, T. Metsvaht, V. Giannuzzi, P. Larsson, P. Pokorná, A. Simonetti, D. Tibboel, . ,

. 2017 ; 7 (6) : e016031. [pub] 20170621

Language English Country England, Great Britain

Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc18024912

INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation. METHODS AND ANALYSIS: The CLOSED study is a multicentre, double-blind, randomised, active-controlled non-inferiority trial with a 1:1 randomisation between clonidine and midazolam. Both treatment groups are stratified according to age in three groups with the same size: <28 days (n=100), 28 days to <2 years (n=100) and 2-18 years (n=100). The primary end point is defined as the occurrence of sedation failure within the study period. Secondary end points include a pharmacokinetic/pharmacodynamic relationship, pharmacogenetics, occurrence of delirium and withdrawal syndrome, opioid consumption and neurodevelopment in the neonatal age group. Logistic regression will be used for the primary end point, appropriate statistics will be used for the secondary end points. ETHICS: Written informed consent will be obtained from the parents/caregivers. Verbal or deferred consent will be used in the sites where national legislation allows. The study has institutional review board approval at recruiting sites. The results will be published in a peer-reviewed journal and shared with the worldwide medical community. TRIAL REGISTRATION: EudraCT: 2014-003582-24; Clinicaltrials.gov: NCT02509273; pre-results.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc18024912
003      
CZ-PrNML
005      
20180711102515.0
007      
ta
008      
180709s2017 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/bmjopen-2017-016031 $2 doi
035    __
$a (PubMed)28637741
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Neubert, Antje $u Department of Children and Adolescents Medicine, Friedrich-Alexander-University Erlangen/Nuremberg, Erlangen, Germany.
245    14
$a The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial / $c A. Neubert, MA. Baarslag, MV. Dijk, JV. Rosmalen, JF. Standing, Y. Sheng, W. Rascher, D. Roberts, J. Winslade, L. Rawcliffe, SM. Hanning, T. Metsvaht, V. Giannuzzi, P. Larsson, P. Pokorná, A. Simonetti, D. Tibboel, . ,
520    9_
$a INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation. METHODS AND ANALYSIS: The CLOSED study is a multicentre, double-blind, randomised, active-controlled non-inferiority trial with a 1:1 randomisation between clonidine and midazolam. Both treatment groups are stratified according to age in three groups with the same size: <28 days (n=100), 28 days to <2 years (n=100) and 2-18 years (n=100). The primary end point is defined as the occurrence of sedation failure within the study period. Secondary end points include a pharmacokinetic/pharmacodynamic relationship, pharmacogenetics, occurrence of delirium and withdrawal syndrome, opioid consumption and neurodevelopment in the neonatal age group. Logistic regression will be used for the primary end point, appropriate statistics will be used for the secondary end points. ETHICS: Written informed consent will be obtained from the parents/caregivers. Verbal or deferred consent will be used in the sites where national legislation allows. The study has institutional review board approval at recruiting sites. The results will be published in a peer-reviewed journal and shared with the worldwide medical community. TRIAL REGISTRATION: EudraCT: 2014-003582-24; Clinicaltrials.gov: NCT02509273; pre-results.
650    _2
$a mladiství $7 D000293
650    _2
$a opioidní analgetika $x aplikace a dávkování $7 D000701
650    _2
$a dítě $7 D002648
650    _2
$a vývoj dítěte $x účinky léků $7 D002657
650    _2
$a předškolní dítě $7 D002675
650    _2
$a clonidin $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D003000
650    _2
$a delirium $x chemicky indukované $7 D003693
650    _2
$a lidé $7 D006801
650    _2
$a hypnotika a sedativa $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D006993
650    _2
$a kojenec $7 D007223
650    _2
$a novorozenec $7 D007231
650    _2
$a jednotky intenzivní péče $7 D007362
650    _2
$a midazolam $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D008874
650    12
$a výzkumný projekt $7 D012107
650    _2
$a umělé dýchání $7 D012121
650    _2
$a abstinenční syndrom $7 D013375
650    _2
$a terapie neúspěšná $7 D017211
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Baarslag, Manuel Alberto $u Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands.
700    1_
$a Dijk, Monique van $u Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands.
700    1_
$a Rosmalen, Joost van $u Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands.
700    1_
$a Standing, Joseph F $u Institute of Child Health, University College London, London, United Kingdom.
700    1_
$a Sheng, Yucheng $u Institute of Child Health, University College London, London, United Kingdom.
700    1_
$a Rascher, Wolfgang $u Department of Children and Adolescents Medicine, Friedrich-Alexander-University Erlangen/Nuremberg, Erlangen, Germany.
700    1_
$a Roberts, Deborah $u Therakind Ltd, London, United Kingdom.
700    1_
$a Winslade, Jackie $u Therakind Ltd, London, United Kingdom.
700    1_
$a Rawcliffe, Louise $u Therakind Ltd, London, United Kingdom.
700    1_
$a Hanning, Sara M $u UCL School of Pharmacy, University College London, London, United Kingdom.
700    1_
$a Metsvaht, Tuuli $u Clinic of Anaesthesiology and Intensive Care, Tartu University Hospital, Tartu, Estonia.
700    1_
$a Giannuzzi, Viviana $u Fondazione per la Ricerca Farmacologica Gianni Benzi onlus, Valenzano, Italy.
700    1_
$a Larsson, Peter $u Department of Pediatric Anesthesia and Intensive Care, Astrid Lindgrens Childrens Hospital, Karolinska University Hospital, Stockholm, Sweden.
700    1_
$a Pokorná, Pavla $u Department of Pediatrics, First Faculty of Medicine, Charles University Prague, Prague, Czech Republic.
700    1_
$a Simonetti, Alessandra $u Clinical Trial Center, Bambino Gesù Children's Hospital, Rome, Italy.
700    1_
$a Tibboel, Dick $u Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands.
700    1_
$a ,
773    0_
$w MED00184484 $t BMJ open $x 2044-6055 $g Roč. 7, č. 6 (2017), s. e016031
856    41
$u https://pubmed.ncbi.nlm.nih.gov/28637741 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20180709 $b ABA008
991    __
$a 20180711102806 $b ABA008
999    __
$a ok $b bmc $g 1317043 $s 1021833
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 7 $c 6 $d e016031 $e 20170621 $i 2044-6055 $m BMJ open $n BMJ Open $x MED00184484
LZP    __
$a Pubmed-20180709
Back

Find record

Citation metrics

Archiving options