Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study

NCT01154179 | Completed DMC

• 1 other identifier: SNE-A01322
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Requiring Artificial Nutrition

Keywords

permissive underfeeding; hypocaloric feeding; artificial nutrition

Outcome Measures

Primary Outcomes (1)

• Septic complication

  average of one week

Secondary Outcomes (5)

• Inflammatory response

  average of one week

• Metabolic response

  average of one week

• Nutrition status

  average of one week

• Systematic complications

  average of one week

• Cost benefit analysis

  average of one week

Study Arms (1)

Normocaloric feeding

NO INTERVENTION

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

Other: Hypocaloric feeding

Interventions

Hypocaloric feeding OTHER

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

Normocaloric feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring artificial nutritional support in the hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scarborough General Hospital: lead

Study Sites (1)

Scarborough General Hospital

Scarborough, North Yorkshire, YO12 6QL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24467878 DERIVED

Study Officials

• Anwar E Owais, MBBS MRCSEd

  Scarborough General Hospital

  PRINCIPAL INVESTIGATOR

• Irfan Kabir, MRCS

  SCarborough General hopital

  PRINCIPAL INVESTIGATOR

• Marcel Gatt, MD

  Scarborough General Hospital

  PRINCIPAL INVESTIGATOR

• Claire Mcnaught, MD

  Scarborough General Hospital

  PRINCIPAL INVESTIGATOR

• John Macfie, MD

  Scarborough General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: April 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

GB (1)