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Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial.
Hepatogastroenterology. 2004 May-Jun; 51(57):757-61.H

Abstract

BACKGROUND/AIMS

Critically ill patients especially who require mechanical ventilation or have coagulopathy are at increased risk for stress-related gastrointestinal hemorrhage. There are conflicting data on the efficacy and complication rates of various prophylactic regimens.

METHODOLOGY

Our single-center randomized, placebo-controlled study included 287 patients with high risk for stress-related upper gastrointestinal hemorrhage (>48 h mechanical ventilation, coagulopathy). We compared 3 prophylactic regimens (proton pump inhibitor--omeprazole 40 mg i.v. once daily, n=72; H2 antagonists--famotidine 40 mg twice a day, n=71; and sucralfate 1 g every 6 hours, n=69) with placebo (n=75) in patients with trauma or after major surgery.

RESULTS

Of 287 assessable patients, clinically significant stress-related upper gastrointestinal bleeding was observed in 1%, 3%, 4%, and 1% of patients assigned to receive omeprazole, famotidine, sucralfate, and placebo, respectively (p>0.28). Bleeding developed significantly more often in patients with coagulopathy compared with the others (10% vs. 2%; p=0.006). The gastric pH (p>0.001) and gastric colonization (p<0.05) was significantly higher in the patients who received pH increasing substances when compared with the other 2 groups. Nosocomial pneumonia occurred in 11% of patients receiving omeprazole, in 10% of famotidine patients, in 9% of sucralfate patients and in 7% of controls (p>0.34). No statistically significant differences were found for days on ventilator, length of ICU stay, or mortality among all the 4 groups.

CONCLUSIONS

We could not show that omeprazole, famotidine, or sucralfate prophylaxis can affect already very low incidence of clinically important stress-related bleeding in high-risk surgical intensive care unit patients. Furthermore, our data suggested that especially gastric pH increasing medication could increase the risk for nosocomial pneumonia. Routine prophylaxis for stress-related bleeding even in high-risk patients seems not to be justified.

Authors+Show Affiliations

Traumatological Hospital Brno, Research Center for Traumatology and Surgery, Czech Republic.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15143910

Citation

Kantorova, Ilona, et al. "Stress Ulcer Prophylaxis in Critically Ill Patients: a Randomized Controlled Trial." Hepato-gastroenterology, vol. 51, no. 57, 2004, pp. 757-61.
Kantorova I, Svoboda P, Scheer P, et al. Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepatogastroenterology. 2004;51(57):757-61.
Kantorova, I., Svoboda, P., Scheer, P., Doubek, J., Rehorkova, D., Bosakova, H., & Ochmann, J. (2004). Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepato-gastroenterology, 51(57), 757-61.
Kantorova I, et al. Stress Ulcer Prophylaxis in Critically Ill Patients: a Randomized Controlled Trial. Hepatogastroenterology. 2004 May-Jun;51(57):757-61. PubMed PMID: 15143910.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. AU - Kantorova,Ilona, AU - Svoboda,Petr, AU - Scheer,Peter, AU - Doubek,Jaroslav, AU - Rehorkova,Dagmar, AU - Bosakova,Hana, AU - Ochmann,Jiri, PY - 2004/5/18/pubmed PY - 2004/7/28/medline PY - 2004/5/18/entrez SP - 757 EP - 61 JF - Hepato-gastroenterology JO - Hepatogastroenterology VL - 51 IS - 57 N2 - BACKGROUND/AIMS: Critically ill patients especially who require mechanical ventilation or have coagulopathy are at increased risk for stress-related gastrointestinal hemorrhage. There are conflicting data on the efficacy and complication rates of various prophylactic regimens. METHODOLOGY: Our single-center randomized, placebo-controlled study included 287 patients with high risk for stress-related upper gastrointestinal hemorrhage (>48 h mechanical ventilation, coagulopathy). We compared 3 prophylactic regimens (proton pump inhibitor--omeprazole 40 mg i.v. once daily, n=72; H2 antagonists--famotidine 40 mg twice a day, n=71; and sucralfate 1 g every 6 hours, n=69) with placebo (n=75) in patients with trauma or after major surgery. RESULTS: Of 287 assessable patients, clinically significant stress-related upper gastrointestinal bleeding was observed in 1%, 3%, 4%, and 1% of patients assigned to receive omeprazole, famotidine, sucralfate, and placebo, respectively (p>0.28). Bleeding developed significantly more often in patients with coagulopathy compared with the others (10% vs. 2%; p=0.006). The gastric pH (p>0.001) and gastric colonization (p<0.05) was significantly higher in the patients who received pH increasing substances when compared with the other 2 groups. Nosocomial pneumonia occurred in 11% of patients receiving omeprazole, in 10% of famotidine patients, in 9% of sucralfate patients and in 7% of controls (p>0.34). No statistically significant differences were found for days on ventilator, length of ICU stay, or mortality among all the 4 groups. CONCLUSIONS: We could not show that omeprazole, famotidine, or sucralfate prophylaxis can affect already very low incidence of clinically important stress-related bleeding in high-risk surgical intensive care unit patients. Furthermore, our data suggested that especially gastric pH increasing medication could increase the risk for nosocomial pneumonia. Routine prophylaxis for stress-related bleeding even in high-risk patients seems not to be justified. SN - 0172-6390 UR - https://www.unboundmedicine.com/medline/citation/15143910/Stress_ulcer_prophylaxis_in_critically_ill_patients:_a_randomized_controlled_trial_ L2 - https://ClinicalTrials.gov/search/term=15143910 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -