The effects of erythromycin on small intestinal transit and nutrient absorption in critical illness

The effects in critically ill patients of erythromycin when compared to placebo on small intestinal transit and nutrient absorption

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000615088

Enrollment

Registered

2010-07-28

Start date

2010-06-10

Completion date

2011-08-09

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

Aims: To evaluate the effects of erythromycin on small intestinal transit and glucose absorption. Hypotheses: Erythromycin will prolong small intestinal transit and, thereby, improve absorption of glucose. Background: Delayed gastric emptying is common in the critically ill and leads to inadequate nutrient delivery. This is usually treated with administration of prokinetic drugs such as erythromycin. While this increases nutrient delivery, the effect on nutrient absorption is unknown. However, in healthy subjects erythromycin has been reported to slow small intestinal transit and thereby increase absorption of nutrient . Research Plan: 15 critically ill patients will be studied in a randomised controlled, double-blind, cross-over fashion on consecutive days. On each study day either intervention (erythromycin 200mg IV) or placebo will be administered from t=-20 to 0min. At t= 0 min a test ‘meal’ consisting of a representative nutrient liquid (1kcal/ml), and 3 grams of 3-O-methyl glucose (3-OMG) mixed with 20MBq 99Tc sulphur colloid will be administered at 2ml/min until t=30 min. Small intestinal transit time will be measured using scintigraphy. Glucose absorption will be measured using plasma concentrations of 3-OMG. Significance: If the hypotheses are proven it would support the use of erythromycin in this group. The alternate outcome (i.e. erythromycin accelerates transit and reduces nutrient absorption) would challenge current feeding protocols common to most Intensive Care Units (ICUs).

Interventions

Erythromycin 200mg in 20mLs, or placebo, administered intravenous (IV) as a single dose between t= -20 and 0 min. A test 'meal' is then administered between t=0 and 30 min and data collected until t =480 min. Patients will be studied on consecutive days (i.e. 24 hour washout period)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Sedated and mechanically ventilated, critically ill patients Aged greater than 17 years, suitable for or receiving post-pyloric nutrition and likely to stay ventilated for at least 48 hours.

Exclusion criteria

Pregnancy, Any contraindication to enteral feeding, Previous surgery on the oesophagus, stomach or duodenum, Any gastrointestinal surgery during their current hospital admission, Contraindication to moderate level of sedation or the use of an opiate for sedation and/or analgesia, Patients receiving erythromycin at an antimicrobial dose, Liver Dysfunction (defined as alanine a minotransferase (ALT) > 3 times the upper limit of normal)

Outcome results