ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical illness

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Drugs

Comparator / control treatment

Placebo is 20 mLs saline administered IV over 20 minutes

Control group

Placebo

Outcomes

Primary outcome [1]

Test null hypothesis Erythromycin has no effect on glucose absorption (measued using plasma 3-O-methylglucose) in critical illness

Timepoint [1]

glucose absorption measured as Area Under Curve (AUC) 3-O-methylglucose between t=0 and 480 min

Primary outcome [2]

Test null hypothesis Erythromycin has no effect on lipid absorption (measued using 13C Triolein breath test) in critical illness

Timepoint [2]

Lipid absorption measured as AUC 13C-Triloein between t = 0 and 480 min

Primary outcome [3]

Test null hypothesis Erythromycin has no effect on small intestinal transit in critical illness

Timepoint [3]

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]

Plasma concentration of Cholecystokinin and Peptide YY and an association with small intestinal transit

Timepoint [1]

t = 0, 30 and 240 min

Secondary outcome [2]

Plasma concentration of motilin and the effect of erythromycin on transit and absorption

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace 
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2009

Approval date [1]

01/12/2009

Ethics approval number [1]

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

Dr Adam Deane

Address

ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 8222 4000

Fax

adam.deane@adelaide.edu.au

Contact person for public queries

Name

Adam Deane

Address

Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 82224000

Fax

+61 8 82222367

adam.deane@adelaide.edu.au

Contact person for scientific queries

Name

Adam Deane

Address

Intensive Care Unit
Level 4
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 82224000

Fax

+61 8 82222367

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

Source	Title	Year of Publication	DOI
Embase	Randomized double-blind crossover study to determine the effects of erythromycin on small intestinal nutrient absorption and transit in the critically ill.	2012	https://dx.doi.org/10.3945/ajcn.112.035691

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically