Introduction: The purpose of this study was to evaluate the effect of omeprazole suspension (SOS) as compared to continuous infusion ranitidine for the prophylaxis of stress ulcers in a randomized clinical trial (RCT). The primary endpoint was incidence of significant upper GI bleeding. Secondary measures included gastric pH control, incidence of pneumonia, adverse effects and costs of acquisition + administration. Methods: Patients were évaluable if they met the following criteria: Critically ill with two or more risk factors for SU (one of which was resp failure w/mechanical ventilation > 48 hrs), gastric pH (measured by bedside pH meter model 6007, Jenco Electronics Ltd, Taipei, Taiwan) of S 4 prior to study entry. Patients were randomized to SOS per ng tube or continuous infusion ranitidine 150-200irtg/24hrs (150mg, n-13 or 200mg, n-12) after receiving a loading dose of 50mg. Results: There were 58 évaluable patients from 4 centers. APACHE 0, ES scores and other variables were comparable in both groups. Clinically significant upper GI bleeding occurred in 4/25 (16%) of those receiving ranitidine and 1/33 (3%) of those receiving SOS (p<0.05). 13/25 (52%) of patients receiving ranitidine developed two consecutive (4 hrs apart) gastric pH measurements S 3.5 vs. 5/33 (15%) in the SOS arm (pO.05). Change in gastric pH after starting ranitidine was 2.2 ±1.4 vs. 4.0 ±1.6 pH units for SOS (p<0.05). Pneumonia developed in 16% of patients in the ranitidine aim and 18% of patients receiving SOS (ns). Serious adverse effects occurred in 3/25 ranitidine and 0/33 SOS. Cost of acquisition admin per day were compared: Ranitidine cont. inf. iv (50mg load x 1, then 150-200mg/24hr) - $20.32 SOS regimen (40mg x 2 on day 1, then 20mg/day) - $12.85 Conclusion: SOS was superior in efficacy, safety and cost when compared to conL i.v. ranitidine in this RCT of pts at high risk of stress ulcération. Thne data independently reproduce the findings of a recent RCT comparing ranitidine and omeprazole.
|Original language||English (US)|
|Journal||Critical care medicine|
|Issue number||1 SUPPL.|
|Publication status||Published - Dec 1 1998|
ASJC Scopus subject areas
- Critical Care and Intensive Care Medicine