OBJECTIVE: To determine the occurrence of upper gastrointestinal hemorrhage in critically ill children, and the efficacy of prophylaxis with almagate (antacid), ranitidine, and sucralfate. DESIGN: Prospective, randomized, controlled trial. SETTING:Pediatric ICU of a tertiary care pediatric hospital. PATIENTS: During a 2-yr study period, 165 patients with one or more upper gastrointestinal hemorrhage risk factors were randomized into one of four groups. Twenty-five patients were excluded because of protocol violations. A total of 140 patients completed the study, with 35 patients in each group. INTERVENTIONS: Patients received no treatment in the control group. The antacid group received almagate 0.25 to 0.5 mL/kg every 2 hrs by nasogastric tube. The ranitidine group received 1.5 mg/kg every 6 hrs iv. The sucralfate group received 0.5 to 1 g every 6 hrs by nasogastric tube. METHODS:Gastric pH and macroscopic bleeding were determined every 2 hrs in all patients until the end of the study. Macroscopic bleeding was classified as nonhemorrhage, slight, or important. Microscopic gastric bleeding was researched with guaiac testing in 72 patients (680 samples). The severity of illness was evaluated by using the Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scores. The risk of upper gastrointestinal hemorrhage was evaluated by the Zinner and Tryba indices, and was modified for children. MEASUREMENTS AND MAIN RESULTS: The occurrence rate of important upper gastrointestinal hemorrhage was higher (by 20%) in the control group than in the rest of the groups (5.7%), p less than .01. There were no differences between the other groups (almagate 5.7%, ranitidine 8.5%, and sucralfate 2.8%). There was a statistically significant correlation between the occurrence rate of important upper gastrointestinal hemorrhage, the scores of severity of illness indices (Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scoring system), the risk of upper gastrointestinal hemorrhage indices (Zinner and Tryba), and mortality rate. The Zinner index better classified the patients in relation to the onset of important upper gastrointestinal hemorrhage (sensitivity 76.9%, specificity 85.8%). CONCLUSIONS: Upper gastrointestinal hemorrhage is an important complication in critically ill children. Prophylaxis with almagate, ranitidine, or sucralfate reduces the occurrence rate of clinically important gastrointestinal hemorrhage.
RCT Entities:
OBJECTIVE: To determine the occurrence of upper gastrointestinal hemorrhage in critically ill children, and the efficacy of prophylaxis with almagate (antacid), ranitidine, and sucralfate. DESIGN: Prospective, randomized, controlled trial. SETTING: Pediatric ICU of a tertiary care pediatric hospital. PATIENTS: During a 2-yr study period, 165 patients with one or more upper gastrointestinal hemorrhage risk factors were randomized into one of four groups. Twenty-five patients were excluded because of protocol violations. A total of 140 patients completed the study, with 35 patients in each group. INTERVENTIONS:Patients received no treatment in the control group. The antacid group received almagate 0.25 to 0.5 mL/kg every 2 hrs by nasogastric tube. The ranitidine group received 1.5 mg/kg every 6 hrs iv. The sucralfate group received 0.5 to 1 g every 6 hrs by nasogastric tube. METHODS: Gastric pH and macroscopic bleeding were determined every 2 hrs in all patients until the end of the study. Macroscopic bleeding was classified as nonhemorrhage, slight, or important. Microscopic gastric bleeding was researched with guaiac testing in 72 patients (680 samples). The severity of illness was evaluated by using the Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scores. The risk of upper gastrointestinal hemorrhage was evaluated by the Zinner and Tryba indices, and was modified for children. MEASUREMENTS AND MAIN RESULTS: The occurrence rate of important upper gastrointestinal hemorrhage was higher (by 20%) in the control group than in the rest of the groups (5.7%), p less than .01. There were no differences between the other groups (almagate 5.7%, ranitidine 8.5%, and sucralfate 2.8%). There was a statistically significant correlation between the occurrence rate of important upper gastrointestinal hemorrhage, the scores of severity of illness indices (Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scoring system), the risk of upper gastrointestinal hemorrhage indices (Zinner and Tryba), and mortality rate. The Zinner index better classified the patients in relation to the onset of important upper gastrointestinal hemorrhage (sensitivity 76.9%, specificity 85.8%). CONCLUSIONS:Upper gastrointestinal hemorrhage is an important complication in critically ill children. Prophylaxis with almagate, ranitidine, or sucralfate reduces the occurrence rate of clinically important gastrointestinal hemorrhage.
Authors: Ahmed F Hawwa; Paul M Westwood; Paul S Collier; Jeffrey S Millership; Shirish Yakkundi; Gillian Thurley; Mike D Shields; Anthony J Nunn; Henry L Halliday; James C McElnay Journal: Br J Clin Pharmacol Date: 2013-05 Impact factor: 4.335