Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Itopride HCI 50 mg

    Drug

    Enteral Itopride 50 mg enterally tid ac

  • Metoclopramide 10 mg ampoule

    Drug

    Intravenous 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

86 Participants
are divided into 2 treatment groups
Group A: ItoprideExperimental treatment 1 intervention
Group B: MetoclopramideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day3

Secondary outcomes

1

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.

Time frame
Day1
2

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.

Time frame
Day 7
3

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)

Time frame
Day 3
4

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

Time frame
Day 4

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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