EAL

CI: Immune-Modulating Enteral Nutrition (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Evaluation of possible benefits of immune-enhancing diet in severe multiple-trauma patients at high risk for SIRS and MOF.

Inclusion Criteria:

Age 18 to 64 years old
Severe multiple injury (Injury Severity Score >20)
Primary admission to trauma center or referral within 24hr.

Exclusion Criteria:

Pregnancy
Significant disease prior to trauma
Renal insufficiency with serum creatinine level of >180 umol/L or dialysis dependence
Liver cirrhosis
Complicated cardiac or pulmonary disease
Insulin-dependent
Diabetes mellitus
Malignancy
Organ transplant
Immunosuppressive drugs
Chemo
Radiotherapy
HIV

Description of Study Protocol:

From 1993 to August 1995, 32 patients with sever multiple injury were enrolled.

After Admission to ICU, patients were randomized to receive either:
- Enteral test diet supplement (Impact)
- Isonitrogenous Isocaloric control diet
Enteral nutrition was scheduled to begin two days after trauma.
Feedings were started at 25ml/hr for 18hrs per day.
Feeding rate increased by 25ml/hr from day to day, Final rate of 150ml/hr.
Simultaneously to EN, pts were also fed Parenterally, until complete complete enteral coverage of the caloric requirments of 25-40 kcal/kg/day was achieved.

Data Collection Summary:

Tolerance of enteral nutrition
Systemic Inflammatory Response and Multiple Organ Failure (SIRS and MOF)
Infection rate
Ventilator Days
ICU length of stay
Hospital length of stay

Description of Actual Data Sample:

Initial N: 32

Attrition (final N): 29 (Immune Diet n=16; Control Diet n=13)

Two excluded d/t uneventful course and could be transferred to on day 4 and 5.
One patient excluded d/t technical problems with feeding tube placement.

Summary of Results:

Findings:

APACHE-II scores (Immune Diet Group 6.5 ± 3 vs. Control Diet 9.8 ± 6.3)
Immune Diet Group significantly less SIRS during 28 days: 8.3 ± 6.3 days with SIRS/pt vs. 13.3 ± 6.7 (p<0.05).
Immune Diet Group significantly lower MOF score on day three and 8-11 (p<0.05).
Mortality was not significantly different.

	Immune-Diet Group (n=16)	Control group (n=13)	Statistical Significance
Pneumonia	10 cases	6 cases	Not significant
Sepsis	-	1 case	Not significant
Bacteremia	1 case	1 case	Not significant
Urinary tract infection	2 cases	1 case	Not significant
Central venous line infection	9 cases	6 cases	Not significant

Ventilator Days	21.4 ± 10.8 days	27.8 ± 14.6	Not significant
ICU Stay	31.4 ± 23.1 days	47.4 ± 32.8	Not significant
Hospital Stay	70.2 ± 52.9 days	58.1 ± 30.1	Not significant

Other Findings:

Immune Diet Group received only 561 ml/day of enteral formula.

Author Conclusion:

Immune-enhancing enteral formula has some beneficial effect on severly injured trauma patients. Significantly fewer days of SIRS per patient and lower scores for MOF were observed, although outcome and hospital stay were not influenced.

Funding Source:

Industry:

Sandoz Nutrition (Switzerland)

Pharmaceutical/Dietary Supplement Company:

Reviewer Comments:

Small Sample Size
Patients received enteral and parenteral nutrition simultaneously may have effected outcomes.
Test group may not have received enough enteral nutrition to show benefit.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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?	N/A
	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

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	N/A
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	N/A
	1.3.	Were the target population and setting specified?	N/A
2.	Was the selection of study subjects/patients free from bias?		???
	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?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
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?	???
	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?	???
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?	No
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	???
	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?	Yes
	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?	???
	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)?	???
	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?	No
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?	No
	10.2.	Was the study free from apparent conflict of interest?	No