Efficacy and Safety of Enteral Erythromycin Estolate in Combination with Intravenous Metoclopramide versus Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients with Enteral Feeding Intolerance: A Randomized, Double-blind Controlled Pilot Study.

BACKGROUND This pilot study aimed to determine the efficacy and safety of enteral erythromycin estolate in combination with intravenous metoclopramide compared to intravenous metoclopramide monotherapy in mechanically ventilated patients with enteral feeding intolerance. METHODS This randomized, double-blind, controlled pilot study included 35 mechanically ventilated patients with feeding intolerance randomized to receive 10 mg metoclopramide intravenously every 6-8 h in combination with 250 mg enteral erythromycin estolate (study group) or placebo every 6 h for seven days. The primary outcome was an administered/target calorie ratio of ≥80% at 48 h, indicating a successful feeding. Secondary prespecified outcomes were daily average gastric residual volume (GRV), total caloric intake, administered/target calorie ratio, hospital length of stay, in-hospital mortality, and 28-day mortality. RESULTS The rate of successful feeding was not significantly different between the study and placebo groups (47.1% and 61.1%, respectively; p = 0.51). The average daily GRV was significantly lower in the study group than in the placebo group (B-coefficient -91.58 (95% Wald CI: -164.35 to -18.8) determined by generalized estimating equation. Other secondary outcomes were comparable, and the incidence of adverse events was not significantly different between the two groups. One common complication was cardiac arrhythmia, which was mostly self-terminated. CONCLUSION Although the combination therapy of enteral erythromycin estolate and intravenous metoclopramide reduced GRV, the successful feeding rate and other patient-specific outcomes did not improve in mechanically ventilated patients with feeding intolerance. This article is protected by copyright. All rights reserved.