Clinical trial NCT01154179: Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study
Official title: Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Requiring Artificial Nutrition
Keywords: permissive underfeeding
hypocaloric feeding
artificial nutrition
Lead sponsor: Scarborough General Hospital
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During patients' stay in the hospital, some of the patients may require artificial feeding for various reasons either through a vein or through a tube going directly to the gut. However, the amount of feeding that can be considered 'adequate' is unclear due to lack of research data. The current evidence the investigators have suggests that doctors might be giving patients more than they require, which might carry some risks. This hasn't been proven until now and there is no evidence as yet to show investigators exactly how much the doctors should feed patients.

The aim of the study is to see whether feeding patients less than what they are currently been feed is associated with better outcome.

The patients will be randomly (like tossing a coin) allocated into 2 groups. One group will get 100% of the current amount; the second group will get 60%. The investigators will then compare the groups to decide if feeding patients less than the current practice is associated with better outcomes.

Detailed description: Aims:

The primary aim of this study is to assess whether hypocaloric feeding in patients receiving artificial nutritional support is associated with reduced septic and non septic morbidity compared to "standard" nutritional support. Secondary end points will include the assessment of metabolic, physiological and clinical responses to the different feeding protocols.

ENTERAL FEEDING OBJECTIVES

1. To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with reduced septic and non septic morbidity compared to "standard" nutritional support.
2. To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in the inflammatory response compared to "standard" nutritional support.
3. To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in metabolic response compared to "standard" nutritional support.
4. To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in nutrition status compared to "standard" nutritional support.
5. To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with differences in systemic complications compared to "standard" nutritional support.
6. To undertake a cost benefit analysis in patients receiving enteral artificial nutritional support, with the assumption that patients receiving hypocaloric feeding will not necessarily manifest lower feeding costs.

PARENTERAL FEEDING OBJECTIVES

1. To investigate whether or not hypocaloric feeding in patients receiving parenteral artificial nutritional support is associated with reduced septic and non septic morbidity compared to "standard" nutritional support.
2. To investigate whether or not hypocaloric feeding in patients receiving parenteral artificial nutritional support is associated with changes in the inflammatory response compared to "standard" nutritional support.
3. To investigate whether or not hypocaloric feeding in patients receiving parenteral artificial nutritional support is associated with changes in metabolic response compared to "standard" nutritional support.
4. To investigate whether or not hypocaloric feeding in patients receiving parenteral artificial nutritional support is associated with changes in nutrition status compared to "standard" nutritional support.
5. To investigate whether or not hypocaloric feeding in patients receiving parenteral artificial nutritional support is associated with differences in systemic complications compared to "standard" nutritional support.
6. To undertake a cost benefit analysis in patients receiving parenteral artificial nutritional support, with the assumption that patients receiving hypocaloric feeding will not necessarily manifest lower feeding costs.

Study Design and Study Group:

This will be a single blind, randomized controlled clinical trial. All patients requiring adjuvant nutritional support will be included in this study. The need for nutritional support and the method of administration (enteral or parenteral) will be decided by the hospital's nutrition team as is present practice.

Clinically, patients requiring supplemental nutrition fall into two clinical groups. Those with a functional gut are fed enterally; the other group, whose gut, for whatever reason, is not functional are fed parenterally. This is the rationale of studying two groups of administration.

Please see Flowchart for exact details. Patients will enter into the parenteral or the enteral component of the stud y in a mutually exclusive manner with no crossover or randomisation occurring at this point. Thereafter, patients in either arm of the study (enteral or parenteral) will be randomised to one of two groups. Comparisons will be done within, but not across, each of the enteral and parenteral arms.

Enteral feeding details:

Enteral control group: patients will receive energy and protein intakes as recommended by the use of Schofield equations (TER=total energy requirements), as is current practice.

Enteral intervention group: patients will be prescribed 60% of recommended (by Schofield) requirements.

Parenteral feeding details:

Parenteral control group : the control group, will receive energy and protein intakes as recommended by the use of Schofield equations, as is current practice.

Parenteral intervention group: patients will be prescribed 60% of recommended (by Schofield) requirements.

Data analysis will be on an "intention to treat" basis. Enteral and parenteral study arms will be analysed separately.

Eligibility criteria: Inclusion Criteria:

* All patients requiring artificial nutritional support in the hospital

Exclusion Criteria:

* Failure to obtain informed consent / assent from next of kin.
* Patients at risk of refeeding syndrome.
* If patients require concomitant enteral and parenteral nutrition.
* Pregnant women and children under the age of 18 years.

Primary outcomes:
measure: Septic complication
timeFrame: average of one week
Secondary outcomes:
measure: Inflammatory response
timeFrame: average of one week
measure: Metabolic response
timeFrame: average of one week
measure: Nutrition status
timeFrame: average of one week
measure: Systematic complications
timeFrame: average of one week
measure: Cost benefit analysis
timeFrame: average of one week
Other outcomes:
Locations:
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: North Yorkshire
Study officials:
affiliation: Scarborough General Hospital
name: Anwar E Owais, MBBS MRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: SCarborough General hopital
name: Irfan Kabir, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Scarborough General Hospital
name: Marcel Gatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scarborough General Hospital
name: Claire Mcnaught, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scarborough General Hospital
name: John Macfie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owais AE, Kabir SI, Mcnaught C, Gatt M, MacFie J. A single-blinded randomised clinical trial of permissive underfeeding in patients requiring parenteral nutrition. Clin Nutr. 2014 Dec;33(6):997-1001. doi: 10.1016/j.clnu.2014.01.005. Epub 2014 Jan 12.