Cisapride improves gastric emptying in mechanically ventilated, critically ill patients. A randomized, double-blind trial.

We conducted a randomized, double-blind, placebo-controlled trial in mechanically ventilated intensive care unit (ICU) patients to evaluate the effect of cisapride on gastric emptying using an acetaminophen absorption model. We enrolled 72 patients expected to remain in the ICU for more than 48 h; 39% were female; the average age was 54.0 +/- 19.1 yr; 47% were postoperative, 83% were receiving narcotics, and the mean simplified acute physiology score (SAPS) was 9.5 +/- 3.0. Within 72 h of admission to ICU, 1.6 g of acetaminophen suspension was administered via a nasogastric tube into the stomach (Day 1). Blood samples were drawn at baseline, 30, 60, 90, 120, and 180 min for measurement of plasma acetaminophen levels. The following morning (Day 2), patients were randomized to receive 20 mg of cisapride or placebo and gastric emptying was again assessed. The difference (Day 2-Day 1) in the maximal plasma concentration was 49.1 mumol/L in the cisapride groups compared with 12.3 mumol/L in the placebo group (p = 0.005) and the time to reach maximal concentration was significantly shorter in the cisapride group (-40.8 min versus -4.2 min, p = 0.02). The difference in area under the time-acetaminophen concentration curve was also greater in the patients receiving cisapride (5,534 versus 2,832, p = 0.09). We conclude that cisapride enhances gastric emptying in critically ill patients. Studies to examine the effect of cisapride on tolerance to enteral nutrition, infectious morbidity, and other clinically important outcomes are warranted.

RCT Entities:   Population Interventions Outcomes