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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-TRC-14004508 |
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Date of registration:
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2014-04-07 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Simultaneous combination of anesthetic and hypothermia to treat refractory status epilepticus
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Scientific title:
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Simultaneous combination of anesthetic and hypothermia to treat refractory status epilepticus |
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Date of first enrolment:
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2013-01-01 |
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Target sample size:
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intervention group:20;intervention group:20; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=5064 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Su Yingying
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Address:
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45 Changchun Street, Xicheng District, Beijing, China
100053
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Telephone:
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+86 15699959572 |
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Email:
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tangsuyingying@sina.com |
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Affiliation:
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Xuanwu Hospital, Capital Medical University |
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Name:
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Su Yingying
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Address:
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45 Changchun Street, Xicheng District, Beijing, China
100053
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Telephone:
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+86 15699959572 |
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Email:
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tangsuyingying@sina.com |
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Affiliation:
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Xuanwu Hospital, Capital Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients were 14 years or older (patients aged less than 14 years is admitted to pediatrics clinics in China); RSE is defined as either clinical or electrographic seizures after receiving adequate doses of an initial benzodiazepine followed by a second acceptable antiepileptic drug (AED).
Exclusion criteria: 1. Unstable vital signs, such as a pulse of <60 beats per minute, a systolic blood pressure of <90 mmHg, or an arterial blood oxygen saturation of <90%;
2. Severe systemic diseases: such as cardiac arrhythmias (second- or third-degree atrioventricular block, sustained ventricular tachyarrhythmia), chronic obstructive pulmonary disease, liver or kidney dysfunction( total bilirubin>34.2µmol/L, Cr>104µmol/L), Coagulation disorders(platelets<75*109/L, INR>1.3, APTT>1.53*upper limit of normal range, Fib<2g/L);
3. Pregnancy;
4. contraindication of anesthetics: such as schizophrenia, depressive state, myasthenia gravis, allergy to benzodiazepines and so on.
Age minimum:
14
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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refractory status epilepticus
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Intervention(s)
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intervention group:intravenous anesthetic;intervention group:hypothermia;
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Primary Outcome(s)
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clinical and(or) EEG termination of seizures;decrease of seizures;recurrence;mortality at 3 months;GOS score at 3 months;circulation inhibition;post-SE symptomatic epilepsy at 3 month;
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Secondary Outcome(s)
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liver dysfunction;kidney dysfunction;EEG patterns before hypothermia;EEG patterns after hypothermia;duration in NICU;duration of hospitalization;
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Source(s) of Monetary Support
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No
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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