Hypocaloric Nutrition in Critically Ill Patients (RuRaL)
| Tracking Information | |||||
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| First Received Date ICMJE | February 7, 2012 | ||||
| Last Updated Date | February 8, 2012 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
SOFA (Sequential Organ Failure Assessment) score [ Time Frame: Every 48 hours since nutritional regime starts and until discharge from ICU ] [ Designated as safety issue: No ] SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, CNS, liver and renal. Each system gets a score from 0 to 4; the maximum SOFA score is 24. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01531335 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Insulin requirements [ Time Frame: Daily until day 21 or discharge from ICU ] [ Designated as safety issue: No ] This is an indirect measure of glycemic control. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hypocaloric Nutrition in Critically Ill Patients | ||||
| Official Title ICMJE | Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial | ||||
| Brief Summary | The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients. |
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| Detailed Description | The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others. The SOFA score will be assessed every two days until discharge from ICU. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Critically Ill | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Colombia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01531335 | ||||
| Other Study ID Numbers ICMJE | SJ0079 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lafrancol S.A. | ||||
| Study Sponsor ICMJE | Lafrancol S.A. | ||||
| Collaborators ICMJE | Hospital Universitario San Ignacio | ||||
| Investigators ICMJE |
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| Information Provided By | Lafrancol S.A. | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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