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Trial registered on ANZCTR


Registration number
ACTRN12610000615088
Ethics application status
Approved
Date submitted
26/07/2010
Date registered
28/07/2010
Date last updated
8/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of erythromycin on small intestinal transit and nutrient absorption in critical illness
Scientific title
The effects in critically ill patients of erythromycin when compared to placebo on small intestinal transit and nutrient absorption
Secondary ID [1] 252301 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 257814 0
Condition category
Condition code
Diet and Nutrition 257985 257985 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 256877 0
Treatment: Drugs
Comparator / control treatment
Placebo is 20 mLs saline administered IV over 20 minutes
Control group
Placebo

Outcomes
Primary outcome [1] 258849 0
Test null hypothesis Erythromycin has no effect on glucose absorption (measued using plasma 3-O-methylglucose) in critical illness
Timepoint [1] 258849 0
glucose absorption measured as Area Under Curve (AUC) 3-O-methylglucose between t=0 and 480 min
Primary outcome [2] 258850 0
Test null hypothesis Erythromycin has no effect on lipid absorption (measued using 13C Triolein breath test) in critical illness
Timepoint [2] 258850 0
Lipid absorption measured as AUC 13C-Triloein between t = 0 and 480 min
Primary outcome [3] 258851 0
Test null hypothesis Erythromycin has no effect on small intestinal transit in critical illness
Timepoint [3] 258851 0
Small intestinal transit will be measured using a scintigraphic technique. Small intestinal transit will be derived from caecal arrival time and rate of caecal filling for up to 240 mins.
Secondary outcome [1] 264969 0
Plasma concentration of Cholecystokinin and Peptide YY and an association with small intestinal transit
Timepoint [1] 264969 0
t = 0, 30 and 240 min
Secondary outcome [2] 264970 0
Plasma concentration of motilin and the effect of erythromycin on transit and absorption
Timepoint [2] 264970 0
t = 0, 30 and 240 min

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent will be obtained from patient next-of-kin. Randomisation drug prepared will be done by the Department of Pharmacy. Allocation concealment will be maintained throughout
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
10/06/2010
Date of last participant enrolment
Anticipated
1/06/2011
Actual
9/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257341 0
Government body
Name [1] 257341 0
National Health and Medical Research Council
Country [1] 257341 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256580 0
None
Name [1] 256580 0
Address [1] 256580 0
Country [1] 256580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259362 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259362 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 259362 0
Australia
Date submitted for ethics approval [1] 259362 0
01/10/2009
Approval date [1] 259362 0
01/12/2009
Ethics approval number [1] 259362 0
081222

Summary
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).
Trial website
nil
Trial related presentations / publications
The results of this study were published in an international medical journal:

Am J Clin Nutr. 2012 Jun;95(6):1396-402.
Randomized double-blind crossover study to determine the effects of erythromycin on small intestinal nutrient absorption and transit in the critically ill.
Deane AM, Wong GL, Horowitz M, Zaknic AV, Summers MJ, Di Bartolomeo AE, Sim JA, Maddox AF, Bellon MS, Rayner CK, Chapman MJ, Fraser RJ.
Public notes

Contacts
Principal investigator
Name 31435 0
Dr Adam Deane
Address 31435 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 31435 0
Australia
Phone 31435 0
+61 8 8222 4000
Fax 31435 0
Email 31435 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 14682 0
Dr Adam Deane
Address 14682 0
Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 14682 0
Australia
Phone 14682 0
+61 8 82224000
Fax 14682 0
+61 8 82222367
Email 14682 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 5610 0
Dr Adam Deane
Address 5610 0
Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 5610 0
Australia
Phone 5610 0
+61 8 82224000
Fax 5610 0
+61 8 82222367
Email 5610 0
adam.deane@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized double-blind crossover study to determine the effects of erythromycin on small intestinal nutrient absorption and transit in the critically ill.2012https://dx.doi.org/10.3945/ajcn.112.035691
N.B. These documents automatically identified may not have been verified by the study sponsor.