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The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quetiapine | Active Comparator | quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. |
|
| placebo | Placebo Comparator | The placebo is made of 100mg of corn starch which is melted in 10cc water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine | Drug | patient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water). |
| Measure | Description | Time Frame |
|---|---|---|
| Development of delirium within 14 days after admitting to ICU (Rate) | 14 days after admitting to intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of delirium occurring within 14 days after admitting to ICU (Days) | 14 days after admitting to ICU | |
| Length of stay in ICU and hospital (Days) | up to 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 29, 2018 | |
| Reset | Dec 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2018 | Dec 20, 2018 |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
| placebo | Drug | The placebo is made of 100mg of corn starch which is melted in 10cc water. |
|
| 60 days in hospital mortality (Rate) |
| 60 days after admitting to ICU |
| Duration of mechanical ventilation in ICU (Days) | 14days after admitting to intensive care unit |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |