NCT03018977|CompletedDMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2018
Actual (reported)Study Completion
April 2018
Actual (reported)Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital. The objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2017
Actual (reported)January 12, 2017
Actual (reported)March 2018
Actual (reported)April 2018
Actual (reported)incidence of withdrawal symptom
72 hour
length of PICU stay
30 days
sedation related adverse events
7 days
We create the new sedative weaning protocol and then use the sedative weaning protocol.
no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
Department of Pediatric,Ramathibodi Hospital
Bangkok, 10400, Thailand
Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med. 2020 Jun;24(6):451-458. doi: 10.5005/jp-journals-10071-23465.
60 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2017
First Posted
January 12, 2017
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Tyrosine Kinase Inhibitor Withdrawal Syndrome in CML Patients: Observatory Trial Studying the Biological Factors.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2018
Actual (reported)Study Completion
April 2018
Actual (reported)Last Updated
April 11, 2018
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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