Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000755831
Ethics application status
Not yet submitted
Date submitted
7/06/2012
Date registered
16/07/2012
Date last updated
16/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Feed and Stop after Twenty hours for Four hours –
Pilot trial of a revised enteral nutrition protocol
Scientific title
A pilot study in the Intensive Care Unit of the safety and acceptability of a cyclic continuous enteral nutrition protocol with increased hourly target rates compared to a non-cyclic continuous enteral nutrition protocol.
Secondary ID [1] 280627 0
NIL
Universal Trial Number (UTN)
Trial acronym
The FAST4 pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill, mechanically ventilated patients 286638 0
Condition category
Condition code
Diet and Nutrition 286953 286953 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group (20 hour protocol) participants will receive prescribed amounts of enteral nutrition following a revised protocol that includes compensatory increase in feeding rates over a set period of 20 hours a day and then fasted for a set period of 4-hours each day.
The prescribed amount given is based on the individual's nutritional assessment and estimation of of the energy and protein requirements . These requirements are calculated using predictive equations as is the common practice by dietitians
The overall duration is a maximum of 12 days or till patient is discharged from the ICU whichever is sooner.

The 20 hour feeding protocol (Intervention group) involves running the prescribed amount for each patient as a continuous infusion for 20 hours per day followed by 4 hours of fasting Example : If a patient's requirements are 1800 calories and the amount prescribed is 1800 ml formula over 24 hours , the infusion will run at a rate of 90 ml /hour (90 ml x 20 = 1800 ml per day)
Intervention code [1] 285025 0
Treatment: Other
Comparator / control treatment
Control group (24 hour protocol) participants will receive prescribed amounts of enteral nutrition following the current 24 hour feeding protocol.
The 24 hour feeding protocol (Control group) involves running the prescribed amount for each patient as a continuous infusion for 24 hours per day . Example : If a patient's requirements are 1800 calories and the amount prescribed is 1800 ml formula over 24 hours , the infusion will run at a rate of 75 ml /hour (75 ml x 24 = 1800 ml per day). There is no fasting period..
Control group
Active

Outcomes
Primary outcome [1] 287278 0
Adequacy of enteral nutrition (Amount of calories and protein received by patients versus amounts prescribed per day by the dietitian), received from enteral nutrition over the first 12 ICU days (or lesser if length of stay <12 days)
Timepoint [1] 287278 0
From the first day of study , daily audit of enrolled participants' charts for first 12 ICU days (or lesser if length of stay <12 days)
Primary outcome [2] 287279 0
Acceptability and safety of the revised feeding protocol
Staff satisfaction survey
A questionnaire will be distributed to the nurses, doctors and dietitians The secondary outcome of this pilot study is the feasibility of the new feeding protocol as judged by a questionnaire that evaluates their opinion of its safety and acceptability. The acceptability of each the novel parts of the feeding protocol and the overall protocol uses a scale where 1 = totally unacceptable and 10 = totally acceptable. This evaluation questionnaire will be administered to all bedside nurse involved in caring for study patients at the end of each nursing shift during the study period and to all medical staff. A minmum of 50 % response rate is anticipated.

Safety endpoints that will be measured are 1. Episodes of reflux, regurgitation or vomiting documented on nursing charts Frequency of diarrhoea (Stools > 300ml liquid per 24 hours), Episodes of high gastric residual volumes ( > 250 ml per 4 hours Ventilator associated pneumonia documented by medical staff, patient positioning daily: measured by researcher daily on rounds,
Management of risk factors or events

All critically ill patients are at risk of developing the above signs and symptoms while on Enteral Nutrition . ICU Standard protocols are followed to manage these conditions for ALL patients. The same protocols will be followed for the study patients.

In addition, two physicians independently will review the charts of all enrolled patients to determine whether episodes of vomiting, regurgitation, macroaspiration (visually noted gastric secretions when suctioning the endotracheal tube), and ventilator-associated pneumonia had occurred. Pneumonia is defined using a definition and process that is standard practice for the ICU doctors .This would determine if there were any undetected serious adverse events related to the nutritional management of the patient and whether the prescription hourly target rates was appropriate and this will be checked off on the data forms. At the discretion of the two physicians and /or the medical team the patient may be discontinued from the study
Timepoint [2] 287279 0
From the first day of study , daily audit of enrolled participants' charts for first 12 ICU days (or lesser if length of stay <12 days)
Secondary outcome [1] 297809 0
Clinical indicator( Length of ICU stay , length of mechanical ventilation , discharge status from ICU, length of hospital stay, discharge status from hospital,60-day mortality, )
Timepoint [1] 297809 0
At the time of discharge from ICU
At the time of discharge from hospital
60 days from the date of admission to ICU
Secondary outcome [2] 298327 0
Nutritional indicator:( Body Mass Index Subjective Global Assessment )
Timepoint [2] 298327 0
At the time of admission
At the time of discharge
Secondary outcome [3] 298328 0
Participants will undergo: Quality of Life assessment with a validated EuorQol 5D (EQ5D) The EQ-5D is a global quality-of-life questionnaire that assesses five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels of severity; no problem to severe problems. The second part of the EQ-5D consists of a vertical visual analogue scale (VAS), where 0 represents the worst imaginable health status and 100 represents the best imaginable health status.
Timepoint [3] 298328 0
At two time points: once on the first day that they are able to do so face-to-face, and the second time through telephone assessments 60 days from the date of admission to ICU (if subjects are survivors).

Eligibility
Key inclusion criteria
Adult patients (>18 years), expected length of stay (LOS) > 72 hrs; mechanically ventilated within 48 hours of admission to the ICU and indicated for enteral nutrition (presence and accessibility of functioning gut and inability to use the oral route for nutrition)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindicated for enteral nutrition for the first 72 hrs of ICU admission (inaccessible or non-functioning gastro-intestinal tract) ; patients on other forms of nutrition support ( oral or parenteral ) either exclusively or in combination with EN, discharged from the ICU less than 72 hours of ICU admission, moribund patients not expected to survive, patients who are not intubated or who receive mask ventilation ,

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)
Patients meeting the study inclusion criteria will be identified by the principal investigator. Persons responsible (eg. family) will be approached for consent to participate in the trial. Patients will be randomly allocated to a control arm ( current feeding protocol) or to an intervention group (revised feeding protocol) using a permuted block randomisation approach. The allocation sequence will be generated by an computerised random number generator which will then be transferred into concealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the permuted block random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Criteria for discontinuation: Patients likely to develop contraindications for enteral nutrition (inaccessible or non-functioning gastro-intestinal tract) during the period of study, patients considered to be at a high risk of experiencing an adverse event as determined by the Medical staff during the period of study,
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2012
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)

Funding & Sponsors
Funding source category [1] 285395 0
Hospital
Name [1] 285395 0
Emerging Researcher Fellowship 2012 awarded to the principal investigator by the Southern Health Research Directorate
Country [1] 285395 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Road, Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 284248 0
None
Name [1] 284248 0
NIL
Address [1] 284248 0
NIL
Country [1] 284248 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287407 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 287407 0
No 246, Clayton Road, Research Directorate, Monash Medical Centre, Southern Health, Clayton 3168, Victoria
Ethics committee country [1] 287407 0
Australia
Date submitted for ethics approval [1] 287407 0
20/06/2012
Approval date [1] 287407 0
Ethics approval number [1] 287407 0

Summary
Brief summary
The purpose of this pilot study is to is to evaluate and assess a revised enteral nutrition protocol to deliver prescribed volumes of nutritional formula through a cyclic (also known as intermittent) 20-hour continuous method .The current enteral nutrition protocol is based on a 24- hour continuous cycle to deliver prescribed volumes of formula. However, various planned processes and events (such as fasting for endotracheal extubation) often interrupt a 24 hour continuous cycle of feeding potentially resulting in sub-optimal levels of nutrition delivery. Hence, the 20 hour continuous method (with a higher rate of feeding per hour) has been developed so that adequate nutrition can be delivered and planned interruptions can take place within the 4 hour non-feeding “gap” period. a minimum of forty patients will be enrolled from the Monash Medical Centre Intensive Care Unit and will be randomly allocated to a control group ( current 24 hour enteral feeding protocol) or an intervention group (revised 20 hour enteral feeding protocol). Data relating to nutritional and clinical outcomes will be collected for up to 12 days for each participant. The hypotheses is that the new protocol will safely and effectively improve current levels of nutritional adequacy from 48 % (based on local audit) closer to the optimal levels recommended in the literature ( > 80 %)
We postulate that this increased provision of calories and protein may translate into improved nutritional and clinical outcomes, but the current study is not powered to demonstrate such a difference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34275 0
Address 34275 0
Country 34275 0
Phone 34275 0
Fax 34275 0
Email 34275 0
Contact person for public queries
Name 17522 0
Rubina Raja
Address 17522 0
No. 246, Clayton Road, Department of Dietetics, Monash Medical Centre, Southern Health, Clayton 3168, Victoria
Country 17522 0
Australia
Phone 17522 0
+613 95944180
Fax 17522 0
+613 95946928
Email 17522 0
[email protected]
Contact person for scientific queries
Name 8450 0
Rubina Raja
Address 8450 0
No 246, Clayton Road Department of Dietetics, Monash Medical Centre, Southern Health, Clayton 3168, Victoria
Country 8450 0
Australia
Phone 8450 0
+613 95944180
Fax 8450 0
+613 95946928
Email 8450 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23227Ethical approval  [email protected]

Results publications and other study-related documents

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