INTermittent ERythromycin versus Infusion: Comparative study in the critically ill (INTERIC study).
- Conditions
- Feeding intolerability in the critically ill patients.Diet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12615001271594
- Lead Sponsor
- Flinders Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is feeding tolerance, as assessed by proportion of participants with Gastric Residual Volume equal or less than 250 ml. This is measured every 4 hours, by the patient's nurse aspirates the nasogastric tube and measuring the total volume. [The primary time point is assessed every 4 hours for the duration of erythromycin/placebo administration.]
- Secondary Outcome Measures
Name Time Method Proportion of patients who experience QT prolongation, assessed by 12 hourly ECG.[Every 12 hours by ECG, up to 7 days, or termination of the infusion.];A report of vomiting by the treating team / patient's nurse.[Any time after the commencement of the infusion and up to stopping the infusion. This will be until day 7, if the infusion wouldn't have been stopped before.];The median and mean of the erythromycin plasma levels, as assessed by specific assay. [Three blood samples will be taken 30 minutes after the first 50 ml intermittent infusion, at 8 hours just before the next 50 ml intermittent infusion and at 24 hours just before the fourth 50 ml intermittent infusion.]