Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001271594p
Ethics application status
Not yet submitted
Date submitted
17/11/2015
Date registered
20/11/2015
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
INTermittent ERythromycin versus Infusion: Comparative study in the critically ill (INTERIC study).
Scientific title
Intermittent versus infusion of Erythromycin for feeding tolerability in the critically ill.
Secondary ID [1] 287904 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INTERIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Feeding intolerability in the critically ill patients. 296780 0
Condition category
Condition code
Diet and Nutrition 297015 297015 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293261 0
Treatment: Drugs
Comparator / control treatment
The control group will receive continuous intravenous infusion of 2 ml/hr of saline and in addition, intermittent single dose infusion of 125 mg erythromycin in 50 ml saline every 8 hours, as per unit protocol. 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.
Control group
Active

Outcomes
Primary outcome [1] 296613 0
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.
Timepoint [1] 296613 0
The primary time point is assessed every 4 hours for the duration of erythromycin/placebo administration.
Secondary outcome [1] 318926 0
Proportion of patients who experience QT prolongation, assessed by 12 hourly ECG.
Timepoint [1] 318926 0
Every 12 hours by ECG, up to 7 days, or termination of the infusion.
Secondary outcome [2] 318951 0
A report of vomiting by the treating team / patient's nurse.
Timepoint [2] 318951 0
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.
Secondary outcome [3] 318952 0
The median and mean of the erythromycin plasma levels, as assessed by specific assay.
Timepoint [3] 318952 0
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.

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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4647 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 12221 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 292396 0
Hospital
Name [1] 292396 0
Flinders Medical Centre
Country [1] 292396 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
ICCU Flinders Medical Centre
Flinders Drive Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 291078 0
None
Name [1] 291078 0
Address [1] 291078 0
Country [1] 291078 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293863 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 293863 0
The Flats F6
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 293863 0
Australia
Date submitted for ethics approval [1] 293863 0
20/11/2015
Approval date [1] 293863 0
Ethics approval number [1] 293863 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61566 0
Dr Shivesh Prakash
Address 61566 0
Intensive and Critical Care Unit
Level 3, Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 61566 0
Australia
Phone 61566 0
+61 8 8204 5511
Fax 61566 0
Email 61566 0
Shivesh.Prakash@sa.gov.au
Contact person for public queries
Name 61567 0
Shivesh Prakash
Address 61567 0
Intensive and Critical Care Unit
Level 3, Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 61567 0
Australia
Phone 61567 0
+61 8 8204 5511
Fax 61567 0
Email 61567 0
Shivesh.Prakash@sa.gov.au
Contact person for scientific queries
Name 61568 0
Shivesh Prakash
Address 61568 0
Intensive and Critical Care Unit
Level 3, Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 61568 0
Australia
Phone 61568 0
+61 8 8204 5511
Fax 61568 0
Email 61568 0
Shivesh.Prakash@sa.gov.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
No additional documents have been identified.