MedDataX Logo

Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study

NCT ID: NCT01154179

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Requiring Artificial Nutrition

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

permissive underfeeding hypocaloric feeding artificial nutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normocaloric feeding

This control group will receive energy and protein intakes as recommended by the use of Schofield equations, as is current practice (100% of requirements)

Group Type NO_INTERVENTION

Hypocaloric feeding

Intervention Type OTHER

This intervention group will be prescribed 60% of recommended (by Schofield) requirements.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypocaloric feeding

This intervention group will be prescribed 60% of recommended (by Schofield) requirements.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Scarborough General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anwar Owais

Mr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anwar E Owais, MBBS MRCSEd

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

Irfan Kabir, MRCS

Role: PRINCIPAL_INVESTIGATOR

SCarborough General hopital

Marcel Gatt, MD

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

Claire Mcnaught, MD

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

John Macfie, MD

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Scarborough General Hospital

Scarborough, North Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24467878 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SNE-A01322

Identifier Type: -

Identifier Source: org_study_id