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INTermittent ERythromycin versus Infusion: Comparative study in the critically ill (INTERIC study).

Intermittent versus infusion of Erythromycin for feeding tolerability in the critically ill.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001271594
Acronym
INTERIC
Enrollment
40
Registered
2015-11-20
Start date
2016-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients whom admitted to the intensive care unit commonly suffer from feeding intolerability. This can cause malnutrition and even increase their chances of dying. Erythromycin which is a kind of antibiotics has been shown that in low doses it can induce feeding tolerance, by acting on a specific targets in the stomach and gut. This study is intended to research whether a continuous infusion of lower dose of erythromycin is better than intermittent administration of the drug.

Interventions

The intervention group is the 'continuous infusion" group. This group will receive 250 mg of erythromycin in 50 ml of saline as a continuous intravenous infusion (2ml/hr) and in addition, intermittent single dose infusion of 50 ml of saline (placebo) every 8 hours. This will be given with single dose metoclopramide 10 mg intravenously every 8 hours. The criteria for stopping the infusion are: A. Home team decides to stop. B. Patient / Family wishes to stop. C. QTc > 500 msec. D. Diarrhoea (as d

The intervention group is the 'continuous infusion" group. This group will receive 250 mg of erythromycin in 50 ml of saline as a continuous intravenous infusion (2ml/hr) and in addition, intermittent single dose infusion of 50 ml of saline (placebo) every 8 hours. This will be given with single dose metoclopramide 10 mg intravenously every 8 hours. The criteria for stopping the infusion are: A. Home team decides to stop. B. Patient / Family wishes to stop. C. QTc > 500 msec. D. Diarrhoea (as defined by more than 3 loose bowel stool a day). E. After 7 days of treatment. All the medications which will be given to the patients will be logged in the patient chart.

Sponsors

Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All of these: (i) Age > 18 years; (ii) availability of informed consent from patient or next of kin (iii)decision by treating clinical to initiate erythromycin for feed intolerance and (iv) patient on metoclopramide.

Exclusion criteria

(i) Pregnancy, (ii) Allergy for macrolide antibiotics or metoclopramide, (iii) QTc greater or equal to 500 msec, (iv) suspected mechanical bowel obstruction or perforation, (v) administration of more than one dose of erythromycin within the previous 24 hrs, (vi) administration of drugs known to interact with erythromycin (carbamazepine, cyclosporine, theophylline, aminophylline, digoxin, oral anticoagulants), (vii) myasthenia gravis (viii) evidence of liver dysfunction (i.e., more than three times elevation above the upper end of normal range of bilirubin, glutamyl transferase, aspartate transaminase, alanine transaminase, or lactate dehydrogenase), (ix) severe renal failure (GFR 15 – 29 ml/min/1.73m2) without renal replacement therapy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026