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IRCT20180112038319N1 IRCT 2018-10-27 Arak University of Medical Sciences Comparison the efficiency of nutrition with entera meal and Ensure and standard gavage of hospital in traumatic patients Comparison the efficiency of nutrition with entera meal standard formula and Ensure and standard gavage of hospital in traumatic patients at ICU in Vali-Asr hospital, Arak. 2018-10-22 anticipated 66 Complete https://irct.ir/trial/30346 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization technique: Simple randomization with randomization table. Patients with similar situation will be chosen. Each patient has a number. The numbers are in randomization table and 66 numbers will be chosen randomly. All the patients have equal chances. Unit of Randomization is person. Researcher and data analyser know the number of patients but they don't know the formula of each patient, Blinding description: This clinical trial will be performed in double blind way That means researcher,data analyser,nurses, hospital personnel and the patient don't know the formula. The formula will be prepared and coded in clean room and will be given to the researcher who gives them to the patients. The preparator knows the formula and others don't know. Data Monitoring Commmittee possess all patient's data. N/A traumatic patients. Intervention 1: First intervention group: Entera meal standard formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient. Intervention 2: Second Intervention group: Ensure formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient. Intervention 3: Control group: Standard gavage of hospital _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient. Yes - There is a plan to make this available What will be shared: All The data can be shared after personal unidentification When: 3 months after Edition of results To whom: Researchers-University professors-Students Conditions: Do not change The data. Use for new clinical trials. Where to obtain: Dr Behnam Mahmoudieh b.mahmodie@arakmu.ac.ir How to obtain: Call Dr Mahmoudieh Comments:
public Shima Shahri
No. 3815163686, nastaran apartment, shahid bazjoo alley, shariati sq, Arak
Arak Iran (Islamic Republic of) 3815163686 +98 86 3221 8317 sh.shahri@arakmu.ac.ir Arak University of Medical Sciences scientific Behnam Mahmoudieh
Vali-asr hospital., vali-asr sq., Arak
Arak Iran (Islamic Republic of) 38149_5_7558 +98 86 3222 2003 b.mahmodie@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 50 Need to Nutrition with NG tube or Gastrostomy or Jejunostomy Multiple trauma 18 years 50 years Both Death Gavage intolerance for more than 24 hours Patient re-NPO for more than 24 hours Reaction to Folate History of DM, hyper or hypothyroidism and metabolic disease Sensitivity to milk protein Gastro-intestinal fistula Burning Renal failure Hepatic failure T79.9 Unspecified early complication of trauma Treatment - Other Treatment - Other Treatment - Other First intervention group: Entera meal standard formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient Second Intervention group: Ensure formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient Control group: Standard gavage of hospital _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient Serum total protein level: Serum albumin and globulin measurement. Timepoint: Serum total protein measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning. Method of measurement: Blood test. Mid arm circumflex. Timepoint: Mid arm circumflex measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning. Method of measurement: non-stretchable tape measure. Serum electrolytes: (Na, K, Ca, Mg). Timepoint: Serum electrolytes measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning. Method of measurement: Blood serum test. NUTRIC score: This factor is designed to quantify the risk of critically ill patients developing adverse events at ICU. It determined with the table(age_APACHE score_SOFA score_ number of co-morbidities_days from hospital to ICU admission). Timepoint: NUTRIC score determination at the beginning of trial(first day) and 8 and 14 days after Formula beginning. Method of measurement: NUTRIC score table. Side effect: diarrhea/Vomiting/Sensitivity. Timepoint: Complication incidence at the beginning of trial(first day) and 8 and 14 days after Formula beginning. Method of measurement: Patient physical examination. Final price of each formula. Timepoint: end of fourteenth day. Method of measurement: Calculation the price of formula. Arak University of Medical Sciences Approved 2017-12-02 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences,basij Sq Arak Markazi Iran (Islamic Republic of)