Delirium Clinical Trial
Official title:
Low-dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Patients in Intensive Care Unit: a Multicenter, Randomised, Double-blinded, Placebo-controlled Trial
Verified date | April 2022 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
For patients undergoing mechanical ventilation, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. In a recent study of the investigators, low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The investigators hypothesize that, for ICU patients with prolonged mechanical ventilation, low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium. The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can reduce the incidence of delirium in ICU patients with prolonged duration of mechanical ventilation (>= 24 hours).
Status | Suspended |
Enrollment | 260 |
Est. completion date | November 2022 |
Est. primary completion date | August 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - aged 18 years or older; - admitted to the ICU; - with expected duration of mechanical ventilation of more than 24 hours. Exclusion Criteria: - refused to participate; - aged less than 18 years; - pregnant; - preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; - inability to communicate in the preoperative period (coma, profound dementia, or language barrier); - brain injury or neurosurgery; - known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or greater atrioventricular block without pacemaker; - severe hepatic dysfunction (Child-Pugh class C); - severe renal dysfunction (undergoing dialysis before surgery); - less likely to survive for more than 24 hours. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Peking University Third Hospital |
China,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain intensity | Assessed twice daily (in the morning from 0600 h to 1000 h and in the evening from 1800 h to 2000 h) with the Numeric Rating Scale (NRS, an 11 point scale where 0 indicated no pain and 10 indicated the worst possible pain). | From enrollment until 7 days. | |
Other | Subjective sleep quality | Assessed in the morning with the NRS (an 11 point scale where 0 indicated the best possible sleep and 10 indicated the worst possible sleep). | From enrollment until 7 days. | |
Primary | Incidence of delirium within the first 7 days after enrollment | Assessment twice daily (in the morning from 0600 h to 1000 h and in the evening from 1800 h to 2000 h) with the Confusion Assessment Method for the ICU (CAM-ICU). | From enrollment until 7 days. | |
Secondary | Duration of mechanical ventilation | Duration of mechanical ventilation after study enrollment. | From enrollment until extubation or 30 days. | |
Secondary | Length of stay in the ICU | Length of stay in the ICU after study enrollment. | From enrollment until ICU discharge or 30 days. | |
Secondary | Length of stay in the hospital | Length of stay in the hospital after study enrollment. | From enrollment until hospital discharge or 30 days. | |
Secondary | Occurrence of non-delirium complications | Occurrence of complications other than delirium after study enrollment. | From enrollment until 30 days. | |
Secondary | All-cause 30-day mortality | All-cause 30-day mortality after study enrollment. | On the 30th day after enrollment. | |
Secondary | 30-day cognitive function | Assessed with the Telephone Interview of Cognitive Status-Modified (TICS-m). | On the 30th day after enrollment. | |
Secondary | 30-day life quality | Assessed with the WHOQOL-Bref. | On the 30th day after enrollment. |
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