A Phase 4 interventional study of lansoprazole OD and placebo in Respiratory Failure, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-08.
Sponsored by Far Eastern Memorial Hospital · Phase 4, Interventional, and Prevention
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 120 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
lansprazole 30 mg qd from NG route or orally
Drug: lansoprazole OD
control group without any PPI, H2 blockers or other medications for treating peptic ulcers.
Drug: placebo
arm 1: lansprazole 30 mg qd from NG route or orally for 14 days
Also known as: Takepron OD for PO QD
takepron placebo
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
Time frame: The first 30 days after RCC admission
30 days mortality rate
Time frame: 30 days
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Far Eastern Memorial Hospital