• Increase Font Size
  • Decrease Font Size
  • View as PDF

SCI: Caloric and Protein Needs in Acute and Rehabilitation Phases (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To quantify excretion of calcium, nitrogen, creatinine, 3-methylhistidine (3MeH), and changes in weight and metabolic rate after complete SCI.

 

Inclusion Criteria:
  • Patients with Frankel class A lesions between the fourth cervical and the tenth thoracic vertebrae
Exclusion Criteria:
  1. Age <16 or >72 years
  2. A lower motor neuron or longitudinal spinal-cord lesions.
Description of Study Protocol:

Recruitment

Patients admitted to the Santa Clara Valley Medical Center Spinal Cord Unit.

Design

  • Descriptive study
  • Case series.

Blinding used (if applicable):  not applicable

Intervention (if applicable)

  • All patients participated a routine rehabilitation program and received standard care: a daily protein 0.8-1.0g/kg, and sufficient calories to meet REE.

Statistical Analysis

  • Within-group and between-group comparisons used paired and unpaired Student's t tests, respectively
  • One-factor repeated-sample ANOVA compared changes occur over the 4 weeks of the study.
Data Collection Summary:

Timing of Measurements

  • Data were collected for 4 weeks or when the flaccid phase of SCI began to resolve.

Dependent Variables

  • Clinical evaluation: Severity of tissue damage, wt, ht, body temperature, biochemical analysis (albumin, calcium).
  • Metabolic studies: Energy expenditure and calorie consumption, urine collection and analysis, stool collection and analysis of nitrogen excretion.

Independent Variables

  • A daily protein 0.8-1.0g/kg, and sufficient calories to meet REE
  • Registered dietitian calculated calorie intake weekly over a 72-hour period from nursing records and patient interviews

Control Variables

Description of Actual Data Sample:

Initial N:  10 SCI patients, 7 men, 3 women 

Attrition (final N):  10 patients

Age:  mean age 32 +/- 19 years

Ethnicity: Not mentioned

Other relevant demographics: 

Anthropometrics:  Five each had cervical and thoracic injuries.

Location:  California

Summary of Results:

Other Findings

  1. Despite trauma, withdrawal syndrome, and hyperthermia, the initial REE were 10% below what was predicted.
  2. Weight decreased by 10%. The cumulative loss amounts to 7.0±0.6kg of the initial body weight (70kg).
  3. Nitrogen excretion paralleled the changes in body weight. The cumulative loss average 235±85g of nitrogen in excess of 300±30g consumed.
  4. Calcium excretion increased for 3 weeks and reached a plateau 150% above baseline.
Author Conclusion:
  • The changes in REE confirmed the previous report showing SCI patients to be hypometabolic.
  • Because nitrogen loss is proportionate to degree of disuse, conditions involving extensive muscle paralysis and disuse may result in excessive nitrogen loss.
  • Comparison with reported values shows the metabolic response exceeds that seen in immobilized patients. Nitrogen excretion rose to levels seen in highly stressed patients and must be considered in the management of patients with acute SCI.
Funding Source:
Government: US Dept. of Education
Reviewer Comments:
  • Study population was small. The results were consistent with previous studies.
  • Generalizable to other acute SCI patients.
  • Comprehensive observations and report.
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? 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? 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? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? N/A
  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? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  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.) N/A
  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? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  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? Yes
  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? 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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  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? ???
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