About this trial
A prospective randomized controlled trial included 86 patients in medicine ward who were diagnosed with feeding intolerance, defined as having a gastric residual volume greater than 200 ml. The patients were randomly assigned to two treatment groups: one receiving enteral metoclopramide and the other receiving intravenous metoclopramide. The primary outcome was the gastric residual volume at 72 hours after treatment. The secondary outcome was gastric residual volume at 24 hours and 7 days after treatment, administered-to-prescribed volume at 72 hours after treatment, the administered-to-target energy ratio and the administered-to-target protein ratio at 96 hours after treatment, the nutrition status evaluated by the Nutrition Alert Form at 7 days after treatment, incidence of adverse events (arrhythmia, pneumonia, diarrhea, vomiting, aspiration), length of hospital stay, ICU length of stay and in-hospital mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized medical patients aged over 18 years who were receiving enteral feeding and had a gastric residual volume (GRV) ≥ 200 ml
Disqualifiers
Use of any prokinetic drug within 24 hours before participating in the study
Known hypersensitivity or contraindication to Metoclopramide or Itopride
Prolonged QTc interval > 460 ms in female >440 ms in male
Hemodynamic instability
Trial design
Parallel
Treatments tested in this trial
Itopride HCI 50 mg
DrugEnteral Itopride 50 mg enterally tid ac
Metoclopramide 10 mg ampoule
DrugIntravenous Metoclopramide (10 mg IV q 6 hours) CrCl 15-60 ml/min: Metoclopramide 5 mg IV q 6 hours CrCl \<15 ml/min: Metoclopramide 5 mg IV q 12 hours Hepatic impairment/ cirrhosis: Metoclopramide 5 mg IV q 6 hours
Treatment groups
Trial outcomes
Primary outcomes
Mean gastric residual volume (in mL) on day 3 after initiation of prokinetics
Mean gastric residual volume (in mL) on day 3 after initiation of prokinetics. The gastric residual volume was recorded four times daily, prior to feeding.
Secondary outcomes
Mean gastric residual volume (in mL) on day 1 after initiation of prokinetics
Mean gastric residual volume (in mL) on day 1 after initiation of prokinetics. The gastric residual volume was recorded four times daily, prior to feeding.
Mean gastric residual volume (in mL) on day 7 after initiation of prokinetics
Mean gastric residual volume (in mL) on day 7 after initiation of prokinetics. The gastric residual volume was recorded four times daily, prior to feeding.
Percentage of prescribed enteral nutrition volume successfully administered on day 3 after initiation of prokinetics
Percentage of prescribed enteral nutrition volume successfully administered on day 3 after initiation of prokinetics. The goal total volume at day 3 was 1200 ml/day. (BD (1 kcal/1ml) 300 ml x 4 feed)
Percentage of target enteral nutrition energy successfully administered on day 4 after initiation of prokinetics
Percentage of target enteral nutrition energy (30 kcal/kg in non-ICU patients, 25 kcal/kg in ICU patients) successfully administered on day 4 after initiation of prokinetics
Locations
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