The effect of IV pantoprazole, omeprazole and pantoprazole oral suspension on the gastric pH.

Phase 3

Conditions: stress related mucosal disease.
erosion (acute) of stomach

Registration Number: IRCT2013092614727N2

Lead Sponsor: Masih Daneshvari National Research Institute of Tuberculosis and Lung Diseases

Brief Summary: Background: Stress-related mucosal disease (SRMD) occurs in many critically ill patients in ICUs and may develop within 24 hours of admission. PPI therapy has been documented to produce more potent inhibition of gastric acid secretion than H2RAs. This study aimed to compare extemporaneously preparation of omeprazole, pantoprazole oral suspension and intravenous pantoprazole on the gastric pH in the ICU patients.<br /> Methods: This was a randomized single blind-study. Patients of =16 years of age with a nasogastric tube, who required mechanical ventilation for =48 hours and thus indicated for gastrointestinal bleeding prophylaxis were eligible for inclusion. The excluded patients were those with active GI bleeding, known allergy to omeprazole and pantoprazole and those intolerant to the oral formulations via nasogastric tube.<br /> Fifty six patients were randomized to treatment with omeprazole suspension 2mg/ml (40 mg every day), pantoprazole suspension 2mg/ml (40mg every day) and intravenous pantoprazole (40 mg every day) for up to 14 days. Gastric aspirates were sampled before and 1-2.5 hours after the drug administration for the pH measurement using an external pH meter. Data were analyzed using SPSS (version 21.0).<br /> Factors correlated to pH were determined. The following variables were investigated: age, sex, APACHE II score, SRMD risk factors, CPIS, baseline pH and the presence of coffee grounds in the samples.<br /> Results: In this study fifty six critically ill patients (39 male, 17 female, mean age:61.5 ± 15.65 Years) were followed for the control of the gastric pH. On each of the 14 trial days the mean of the gastric pH alteration was significantly higher in omeprazole and pantoprazole suspension-treated patients than in intravenous pantoprazole-treated patients. (p

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 56

Inclusion Criteria

patients of =16 yrs of age; anticipated stay of =72 hrs in ICU; required mechanical ventilation more than 48 hrs; APACHE II score =11; have a nasogastric or orogastric tube in place; have at least one additional risk factor for upper GI bleeding
Exclusion criteria: status of no CPR; delay of >48 hrs from time of initial eligibility; history of gastric surgery; allergy to omeprazole or pantoprazole; active GI bleeding; significant risk of swallowing blood; admission for upper GI surgery; known upper GI lesions that might bleed; inability to take a suspension by nasogasrtic tube; end- stage liver disease

Exclusion Criteria

Not provided