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Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154179
First Posted: June 30, 2010
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anwar Owais, Scarborough General Hospital
  Purpose

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.


Condition Intervention
Patients Requiring Artificial Nutrition Other: Hypocaloric feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study

Further study details as provided by Anwar Owais, Scarborough General Hospital:

Primary Outcome Measures:
  • Septic complication [ Time Frame: average of one week ]

Secondary Outcome Measures:
  • Inflammatory response [ Time Frame: average of one week ]
  • Metabolic response [ Time Frame: average of one week ]
  • Nutrition status [ Time Frame: average of one week ]
  • Systematic complications [ Time Frame: average of one week ]
  • Cost benefit analysis [ Time Frame: average of one week ]

Enrollment: 93
Study Start Date: April 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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)
Other: Hypocaloric feeding
This intervention group will be prescribed 60% of recommended (by Schofield) requirements.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154179


Locations
United Kingdom
Scarborough General Hospital
Scarborough, North Yorkshire, United Kingdom, YO12 6QL
Sponsors and Collaborators
Scarborough General Hospital
Investigators
Principal Investigator: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anwar Owais, Mr, Scarborough General Hospital
ClinicalTrials.gov Identifier: NCT01154179     History of Changes
Other Study ID Numbers: SNE-A01322
First Submitted: June 29, 2010
First Posted: June 30, 2010
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Anwar Owais, Scarborough General Hospital:
permissive underfeeding
hypocaloric feeding
artificial nutrition