CI: Enteral Nutrition vs. Parenteral Nutrition (2012)

Citation:

Kalfarentzos, F, Kehagias N, Kokkinis MK, Gogos CA. Enteral nutrition is superior to parenteral nutrition in severe acute pancreatitis: results of a randomized prospective trial.  BJN; 1997, 84:1665-1669.

PubMed ID: 9448611
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
What is the effect of enteral feeding versus parenteral feeding on efficacy, tolerance, cost and clinical outcome in acute pancreatitis patients?
Inclusion Criteria:

3 or more criteria according the Imrie classification or APACHE II score of 8 or more. C reactive protein greater than 120 mg/L within 48 hours of admission Grade D or E by CT exam  according to the Balthazar critieria.

Exclusion Criteria:
Patients who were treated elsewhere for more than 2 days before admission to the hospital was not included.
Description of Study Protocol:

Pts received either enteral feeding by NG tube with a semi-elemental  diet or received parenteral nutrition throw a central venous catheter. 

Enteral feeding and parenteral feeding was begun post op.

Target rate in both groups was to provide 1.5-2.0 grams of protein per kg per day and 30-35 Kcal per Kg per day.  Full strength enteral feeding was started at 25 ml and advanced by 25 ml every 4 hours until patients target rate was reached.

TPN was infused at 40 ml/hr and advanced by 20 ml/h every 4 hours until target rate reached.

Data Collection Summary:

C reactive protein was measured 3X week. Blood cultures were performed at least twice a week. Bacteriological culture of urine was performed twice a week. Success of nutritional support was determined by nitrogen balance. At the time of hospital discharge, patient records were reviewed for confirmation of complications during the course of the disease and classified as:

  • Those related to artificial nutrition support
  • Those due to acute pancreatitis
  • Those due to other septic complication
  • Length of hospital stay determiend
  • Length of ICU stay
  • Number of days on artificial ventilation
  • Number of days receiving tube feedings or tpn
  • Number of antibiotics and number of antibiotic days.
  • Mean cost of EF or TPN
Description of Actual Data Sample:
Summary of Results:

38 Patients acute severe pancreatitis were randomized into two groups.

  • No differences for total number of days on specialized nutrition support
  • No differences in protein intake between groups
  • No significant differences in nitrogen balance
  • Diarrhea developed in 3 TPN patients and 6 EN patients
  • Hyperglycemia occurred in 14 in EN Group and 18 in the TPN group
  • EF groups had significantly less morbidity than the TPN group p<0.05
  • The mean number of infections per patient was significantly lower in patients receiving EN vs TPN. P<0.01.
  • One death in the EF group, two deaths in the TPN Group.
  • Cost was higher  (3 X) in the TPN group when compared to the EN group.
Author Conclusion:

Enteral feeding may be successfully implemented in this acute care population (90% rate of tube placement without complications). Risk of developing complications from TPN is 3.47 times higher than when enteral nutrition is successfully implemented in this population of severe pancreatitis patients.

Favors enteral nutrition over parenteral nutrition in acute pancreatitis patients

Funding Source:
Government: NIH
University/Hospital: Universtiy of Cincinnati Medical Center
Reviewer Comments:

Small but well executed clinical study.

Important clinical measures. 

Peptide based formula used, not polymeric. 

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? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? No
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) No
 
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? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? No
  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? No
  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? ???
  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.) No
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? No
4. Was method of handling withdrawals described? No
  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%.) ???
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  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.) ???
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? ???
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? ???
  5.5. In diagnostic study, were test results blinded to patient history and other test results? ???
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? ???
  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? No
  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? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? ???
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? ???
  6.8. In diagnostic study, were details of test administration and replication sufficient? ???
7. Were outcomes clearly defined and the measurements valid and reliable? ???
  7.1. Were primary and secondary endpoints described and relevant to the question? ???
  7.2. Were nutrition measures appropriate to question and outcomes of concern? ???
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? ???
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? No
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? No
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? ???
  8.2. Were correct statistical tests used and assumptions of test not violated? ???
  8.3. Were statistics reported with levels of significance and/or confidence intervals? ???
  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)? ???
  8.6. Was clinical significance as well as statistical significance reported? ???
  8.7. If negative findings, was a power calculation reported to address type 2 error? ???
9. Are conclusions supported by results with biases and limitations taken into consideration? No
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
10. Is bias due to study's funding or sponsorship unlikely? ???
  10.1. Were sources of funding and investigators' affiliations described? ???
  10.2. Was the study free from apparent conflict of interest? ???