Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and sucralfate. The Gastrointestinal Hemorrhage Study Group.
OBJECTIVE
To determine the occurrence of upper gastrointestinal hemorrhage in critically ill children, and the efficacy of prophylaxis with almagate (antacid), ranitidine, and sucralfate.


METHODS
Prospective, randomized, controlled trial.


METHODS
Pediatric ICU of a tertiary care pediatric hospital.


METHODS
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.


METHODS
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.


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.
López-Herce
J
J
Pediatric Intensive Care Unit, La Paz Children's Hospital, Madrid, Spain.
Dorao
P
P
Elola
P
P
Delgado
M A
MA
Ruza
F
F
Madero
R
R
D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D000863:Antacids / Q000009:adverse effects / Q000627:therapeutic use*; D002254:Carbonates / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002648:Child; D016638:Critical Illness; D016002:Discriminant Analysis; D004341:Drug Evaluation; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology* / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D008276:Magnesium Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011899:Ranitidine / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013030:Spain / Q000453:epidemiology; D013392:Sucralfate / Q000009:adverse effects / Q000627:therapeutic use*
D000863:Antacids; D002254:Carbonates; D013392:Sucralfate; C043698:almagate; D000536:Aluminum Hydroxide; D011899:Ranitidine; D008276:Magnesium Hydroxide