Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study
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|ClinicalTrials.gov Identifier: NCT01154179|
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : September 5, 2012
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 or disease||Intervention/treatment||Phase|
|Patients Requiring Artificial Nutrition||Other: Hypocaloric feeding||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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.
- Septic complication [ Time Frame: average of one week ]
- 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 ]
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
|Scarborough General Hospital|
|Scarborough, North Yorkshire, United Kingdom, YO12 6QL|
|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|