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The purpose of this study is to determine whether lansoprazole administered nasogastrically is effective for stress ulcer prophylaxis in respiratory intensive care unit.
Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Lansoprazole has good acid suppression effect and the tablets are soluble for the use of tube feeding. There was no data about the prophylaxis of stress ulcer development during the program of weaning from the mechanical ventilators. Therefore, we conduct a study of the comparison of lansoprazole administered nasogastrically and control group for stress ulcer prophylaxis in respiratory intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | lansprazole 30 mg qd from NG route or orally |
|
| 2 | Placebo Comparator | control group without any PPI, H2 blockers or other medications for treating peptic ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lansoprazole OD | Drug | arm 1: lansprazole 30 mg qd from NG route or orally for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overt UGI bleeding: (1)tarry stool or coffee ground substance or fresh blood from NG≥ 60ml (2)blood component transfusion for more than PRBC 2 units 3)PES or TAE or surgical intervention for hemostasis | The first 30 days after RCC admission |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality rate | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chu C Lin, MD | Far Eastern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Taipei | 22050 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8284001 | Background | Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601. | |
| 15483408 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| placebo | Drug | takepron placebo |
|
| Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13. doi: 10.1097/01.ccm.0000142398.73762.20. |
| 9934901 | Background | Lam NP, Le PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103. doi: 10.1097/00003246-199901000-00034. |
| 9339962 | Background | Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. doi: 10.2165/00003495-199754040-00005. |
| 8930427 | Background | Chun AH, Shi HH, Achari R, Dennis S, Cavanaugh JH. Lansoprazole: administration of the contents of a capsule dosage formulation through a nasogastric tube. Clin Ther. 1996 Sep-Oct;18(5):833-42. doi: 10.1016/s0149-2918(96)80043-9. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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