Effects of early versus delayed enteral nutrition and closed versus open enteral nutrition on high-sensitivity C-Reactive Protein and Tumor Necrosis Factor Alpha in 24 patients admitted in surgery Intensive Care Units
The objective of this randomized single-blind study is to essay affects of early versus delayed enteral nutrition feeding as well as closed versus open enteral nutrition formula on serum high-sensitivity C-Reactive Protein and Serum Tumor Necrosis Factor Alpha among patients admitted in surgery intensive care unit. Effects of each groups of intervention will be essayed on Simplified Acute Physiology Score (SAPS II) and Sequential Organ Failure Assessment Score (SOFA), too. Patients will be divided into four groups, randomly, after filling constant forms. Half of subject will receive early enteral feeding and the rest will nourished by delayed enteral feeding. Each group will be divided into two sub-groups: subject will be fed by closed formula and those subjects that will be fed by open formula. Duration of the study is 7 days. Subjects will be included if their Acute Physiology and Chronic Health Evaluation (APACHE) score will be between 15 to 25 and be stayed in intensive care units for at least 72 hours. Patients will be excluded if aged less than 18 years or have hepatic or nephritic syndromes. Total number of subjects will be 24. Primary outcome is to essay affects of early versus delayed enteral nutrition feeding and closed versus open enteral nutrition formula on serum high-sensitivity C-Reactive Protein and serum Tumor Necrosis Factor Alpha.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403042017N19
Registration date:2014-04-13, 1393/01/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-13, 1393/01/24
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of early versus delayed enteral nutrition and closed versus open enteral nutrition on high-sensitivity C-Reactive Protein and Tumor Necrosis Factor Alpha in 24 patients admitted in surgery Intensive Care Units
Public title
Effects of early versus delayed enteral nutrition and closed versus open enteral nutrition on high-sensitivity C-Reactive Protein and Tumor Necrosis Factor Alpha in 24 patients admitted in surgery Intensive Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: aged more than 18 years; those who might be stayed in Intensive Care Units for more than 72 hours; Patients with Acute Physiology and Chronic Health Evaluation more than 15-25. Exclusion criteria: aged less than 18 years; patients with hepatic disorders; patients with nephritic syndrome; Hemodinamically unstable; increased lactate in serum; Pregnant women.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of Medical Sciences
Street address
Golgasht St.
City
Tabriz
Postal code
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
92205
Health conditions studied
1
Description of health condition studied
Unspecified protein-energy malnutrition
ICD-10 code
E46
ICD-10 code description
Protein-energy imbalance NOS
Primary outcomes
1
Description
Serum high-sensitivity C-Reactive Protein
Timepoint
In first, third, fifth and seventh days
Method of measurement
Blood sampling
2
Description
Serum Tumor Necrosis Factor Alpha
Timepoint
In fiollowing days: first, third, fifth and seventh.
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Simplified Acute Physiology Score (SAPS II)
Timepoint
In following days: first, third, fifth and seventh .
Method of measurement
By measuring following parameters: Type of admission، , Chronic diseases, Glasgow , ، Syst. Blood Pressur, ، If MV or CPAP ، PaO2/FIO2(mmHg), ، Urine output, ، WBC,، Potassium,، Sodium,، HCO3,، Bilirubin,، Serum Urea or ، BUN, ، Heart rate,، Temperature
2
Description
Sequential Organ Failure Assessment Score (SOFA)
Timepoint
In following days: first, third, fifth and seventh
Method of measurement
PaO2/FiO2 (mmHg), Glasgow coma scale, Mean Arterial Pressure, Bilirubin (mg/dl) , Platelets×103/µl, Creatinine (mg/dl)
Intervention groups
1
Description
Enteral feeding by open and closed formula in delayed and early feeding groups over 7 days