Unique ID issued by UMIN | UMIN000037989 |
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Receipt number | R000043283 |
Scientific Title | Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study |
Date of disclosure of the study information | 2019/09/20 |
Last modified on | 2020/07/04 11:25:14 |
Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study
Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study
Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study
Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study
Japan |
Agitation in the intensive care unit
Intensive care medicine |
Others
NO
To estimate efficacy and safety of zotepine in critically ill patients with agitation
Safety,Efficacy
Proportion of patients with Intensive Care Delirium Screening Checklist < 4 on the next observation day following first dose
Proportion of patients with maximum blood glucose level 180 mg/dL or more for 24 hours after taking study drug
Interventional
Parallel
Non-randomized
Single blind -participants are blinded
Active
2
Treatment
Medicine |
Administration of zotepine 25-50 mg at a time, additional dose can be given 8 hours later.
Administration of quetiapine 25-50 mg at a time, additional dose can be given 8 hours later.
16 | years-old | < |
Not applicable |
Male and Female
1. Age 16 years old and more
2. Enteral nutrition can be administered
3. The physician considered the use of propofol newly in Richmond Agitation-Sedation Scale + 1 and more (agitation)
1. Intensive Care Delirium Screening Checklist 3
and less
2. Admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage, active seizure)
3. History of hepatic encephalopathy or end-stage liver disease
4. Actively withdrawing from alcohol
5. Treatment with an antipsychotic agent in the 30 days before ICU admission
6. Current treatment with a neuromuscular blocker
7. Current treatment with an agent having either the potential to affect quetiapine concentrations (e.g., phenytoin)
8. Increase the risk for QTc prolongation
9. Baseline QTc interval 500 sec and more
10. Pregnancy
11. Non-Japanese speaking
12. Presence of a condition preventing of assessment Intensive Care Delirium Screening Checklist
13. Prognosis considered hopeless
14. Refused by the patient or family
15. The decision of physician
25
1st name | Shodai |
Middle name | |
Last name | Yoshihiro |
JA Hiroshima General Hospital
Pharmaceutical Department
7388503
1-3-3 Jigozen, Hatsukaiti-shi, HIROSHIMA, JAPAN
0829-36-3111
syoshihiro-ja@umin.ac.jp
1st name | Shodai |
Middle name | |
Last name | Yoshihiro |
JA Hiroshima General Hospital
Pharmaceutical Department
7388503
1-3-3 Jigozen, Hatsukaiti-shi, HIROSHIMA, JAPAN
0829-36-3111
syoshihiro-ja@umin.ac.jp
Pharmaceutical Department, JA Hiroshima General Hospital and Division of Emergency and Critical Care Medicine, JA Hiroshima General Hospital
None.
Self funding
JA Hiroshima General Hospital IRB
1-3-3 Jigozen, Hatsukaiti-shi, HIROSHIMA, JAPAN
0829-36-3111
jahiroshimahp@hirokouren.or.jp
NO
JA広島総合病院
2019 | Year | 09 | Month | 20 | Day |
Unpublished
Completed
2015 | Year | 04 | Month | 10 | Day |
2015 | Year | 04 | Month | 10 | Day |
2015 | Year | 08 | Month | 01 | Day |
2019 | Year | 09 | Month | 10 | Day |
2019 | Year | 11 | Month | 01 | Day |
2019 | Year | 11 | Month | 01 | Day |
2019 | Year | 11 | Month | 01 | Day |
2019 | Year | 09 | Month | 11 | Day |
2020 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043283
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