CI: Enteral Nutrition and Fiber (2011)
Chittawatanarat K, Pokawinpudisnun P, Polbhakdee Y. Mixed fibers diet in surgical ICU septic patients. Asia Pac J Clin Nutr. 2010; 19 (4): 458-464.PubMed ID: 21147705
Demonstrate effects of enteral formula containing mixed (soluble and insoluble) fiber on critically-ill patients who needed antibiotics and were hospitalized in a general ICU.
- Septic patients who received broad spectrum antibiotics and EN
- Hospitalized in the general ICU during the period of February 2007 to November 2008.
- Hemodynamic instability
- Bowel obstruction, hemorrhage, ileus
- Acute pancreatitis
- Post-endoscopy under 24 hours
- Ischemic bowel
- Inflammatory bowel, ulcerative colitis, Chron's disease
- Enteric fistula
- Malabsorptive syndrome
- Eligible patients who did not sign informed consent.
- Recruitment: Patients in a six-bed ICU during the 19-month study period, who met inclusion criteria and signed informed consent
- Design: RCT (randomization scheme not described)
- Blinding used: Double-blind trial.
- Intervention Group received EN formula containing mixed fiber (Nutren Fibre®)
- Control Group received standard EN formula without fiber (Nutren Optimum®)
- All patients received formula for five or more days.
- Mean and standard deviation in normal distribution continuous data
- X2 or Fisher's exact test for analysis of categorical data
- Student's T-test for variables with normal distribution
- Mann-Whitney U-test for variables without normal distribution.
- Timing of measurements: Recorded each incidence of diarrhea
- Dependent variables: Diarrhea (score according to Hart and Dobb method)
- Independent variables: Type of EN formula (with or without fiber)
- Control variables: Medications known to cause diarrhea prohibited in all patients.
- Initial N: 34 (12 males, 22 females)
- Attrition: Final N=31 (one died in the Fiber Group and two died in the Control Group)
- Age: Mean, 50 years (P=0.68 between groups)
- Ethnicity: Not described.
Other Relevant Demographics
- Mean APACHE score (P=0.83)
- Fiber: 19.8±4.2 (95% CI, 17.6-22.0)
- No fiber: 22.2±6.6 (95% CI, 16.8-23.6).
- Albumin (P=0.37)
- Fiber: 3.1±0.8 (95% CI, 2.7-3.5)
- No fiber: 2.9±0.9 (95% CI, 2.4-3.3).
- No difference by group in energy intake.
No differences in groups by weight (P=0.69).
Chiang Mai University, Thailand.
No Fiber Group
Statistical Significance of Group Difference
Diarrhea Score >12
Diarrhea Score (mean)
Overall Incidence of Diarrhea Density per 100 Patient-Fed Days
IRR, 0.45 (95% CI, 0.2-0.9; P=0.01)
|ICU LOS Days (mean, range)||
|Hospital LOS Days (mean, range)||
Repeated-measures model confirmed that diarrhea scores were statistically different: Coefficient of Fiber Group was -3.03 (95% CI, -5.0 to -0.9; P=0.01).
Formula containing mixed fiber reduced diarrhea scores in critically-ill septic patients who required broad spectrum antibiotics.
|University/Hospital:||Chiang Mai University, Thailand|
|In-Kind support reported by Industry:||Yes|
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||No|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||Yes|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||N/A|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||Yes|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||Yes|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||N/A|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||N/A|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||N/A|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||Yes|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|