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The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole Sodium | Active Comparator | 40 mg twice daily (q12h) |
|
| Ilaprazole Sodium | Experimental | 10 mg once daily, 20 mg dosed in the first day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 40mg | Drug | 40 mg i.v. twice daily (q12h) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Preventing clinically significant gastrointestinal bleeding | (1) Bright red blood is observed in gastric tube and not cleared by gavage washing with at least 100mL of standard physiological saline at room temperature for 5 to 10 minutes; | Day 1 to Day 3 |
| Preventing clinically significant gastrointestinal bleeding | (2) During the Day 1 to Day 2 days of the treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, every 2 hours (± 20 minutes) from the time of first observation, and the coffee-like substances were still observed after 8 hours (the occult blood screening reagent remains positive, and the occult blood result is required to be positive); | Day 1 and Day 2 |
| Preventing clinically significant gastrointestinal bleeding | (3) On the Day 3 of the treatment - end of treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, once per hour (± 20 minutes), and the coffee-like substances are still observed after 4 hours (occult blood screening reagent continues to be positive, and occult blood results are required to be positive). | Day 3 |
| Preventing clinically significant gastrointestinal bleeding | (4) Hematemesis or bloody stools originating from the upper gastrointestinal tract (as determined by the researchers, such as tarry stools and positive gastric occult blood). | Day 1 to Day 3 |
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Inclusion Criteria:
voluntarily signed informed consent form by subjects per se or their guardians.
18-74 years of age, female or male;
required by the ICU treatment, and is intended to be treated over 72 hours.
intragastrically intubated for at least 72 hours;
APACHE II scoring within 15 to 25 (containing upper and lower value)
intubated by mechanical assistance for breath for intended 48 hours without permission of assistance withdrawal. (Combing clinical observation, patients judged cannot breathing without artificial assistance within 48 hours should meet the any of criteria as following: 1) PEEP > 5; 2) FiO2 > 0.4; 3) Pressure of assisting breathing machine > 13 cmH2O; 4) body temperature over 38℃; 5) CRP ≥ 100 mg/L.
in addition to mechanical ventilation, at least one major factor that may lead to irritable ulcer bleeding occurred as following within 48 hours prior to random group-assignment.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University Affiliate Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China | ||
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| Ilaprazole Sodium |
| Drug |
10 mg i.v. once daily, 20 mg i.v. in the first day. |
|
| Placebo 1 | Drug | Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h. |
|
| Placebo 2 | Drug | Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day. |
|
| The First Affiliated Hopspital of Xinjiang Medical University |
| Ürümqi |
| Xinjiang |
| China |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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