ONC: Hematopoietic Cell Transplant (2006)
Skop A, Kolarzyk E, Skotnicki AB. Importance of parenteral nutrition in patients undergoing hematopoietic stem cell transplantation in the autologous system. J Parenter Enteral Nutr. 2005: 29(4), 241-247.
PubMed ID: 15961679- All patients with neoplasm of the hemopoietic system
- Underwent hemopoietic cell autotransplantation at the Hematology Clinic, Jagiellonian University, Krakow, Poland in the period 2001-2003
- Not Reported
Recruitment: All subjects undergoing HCT at at the Hematology Clinic, Jagiellonian University, Krakow, Poland in the period 2001-2003 were approached for consent.
Design: Depending upon oral tolerance, assessed on a daily basis, patients were assigned to receive When parenteral nutrition (PN) (n=19, 54.3%) or oral nutrition (ON) (n=16, 45.7%). Daily requirements were estimated to be 25-30 Kcal/kg and 1.0-1.5g protein/kg.
Efficacy of nutrition intervention was evaluated on the basis of:
- Clinical Condition
- Respiratory efficiency
- Circulatory system efficiency
- Nitrogen balance
- Using UUN based on 24-hour urine collections
- N balance = nitrogen intake - (UUN + 4g/day)
- Nutrition assessment (assessed pre-HCT, transplant day, day of granuolcyte recovery, discharge day)
- Height
- Weight
- BMI
- Biochemical indices (albumin, total protein)
- Body composition (BIA)
- Clinical status
- Hematologic recovery (granulocyte >500/µL; leukocytes >1500/µL; platelets >20,000/µL)
- Enzyme activity (ALT, AST, t-bilirubin)
- Infections
- LOS
Blinding used (if applicable): Not applicable
Intervention (if applicable):
Nutritional needs were estimated at 25-30 Kcal/kg and 1.0-1.5g protein/kg. Five low bacterial meals were provided daily. If necesary oral intake was supplemented with 2-4 cartons of Nutridrink to provide 600-1200 kcal and 20-40g protein.
PN was initiated if oral intake provided <50% of estimated requirements over 2 days however, oral nutrition was encouraged. PN was reduced over 1-2 days then discontinued, once oral intake exceeded 50% of 24-hour requirement. Caloric needs in PN patients were estimated using the Harris Benedict formula. PN provided 25-30 Kcal/kg and 1.0-1.5g protein/kg in a total nutrient admixture (TNA) with:
- 20-30% kcal from lipid
- 15-25% kcal from amino acids
- 50-55% kcal from glucose
Statistical Analysis
The data ws non-normally distributet so nonparametric tests were used
- Mann-Whitney test and Friedman test (nutrition and clinical status)
- Descriptive statistics (LBM, body composition)
- p value <= 0.05
- Statistics for Windows 6.0
Timing of Measurements
Daily measurements:
- Weight
- Oral tolerance
- Hematological indices
- Infections
Three times a week:
- Liver enzymes
Pre-HCT, transplant day, day of granuolcyte recovery, discharge day:
- Clinical Condition
- Respiratory efficiency
- Circulatory system efficiency
- Nitrogen balance
- Using UUN based on 24-hour urine collections
- N balance = nitrogen intake - (UUN + 4g/day)
- Nutrition assessment
- Height
- Weight
- BMI
- Biochemical indices (albumin, total protein)
- Body composition (BIA)
Dependent Variables
- Variable 1: Clinical status as measured by:
- Hematologic recovery (granulocyte >500/µL; leukocytes >1500/µL; platelets >20,000/µL)
- Enzyme activity (ALT, AST, t-bilirubin)
- Infections
- LOS
- Variable 2: Nutrition status as measured by:
- Height
- Weight
- BMI
- Biochemical indices (albumin, total protein)
- Body composition (BIA)
Independent Variables
- Nutrient provision via PN
Initial N: 35 (PN (n=19) 7 female, 12 male; ON (n=16) 12 female, 4 male)
Attrition (final N): 35 (PN (n=19) 7 female, 12 male; ON (n=16) 12 female, 4 male)
Age:
- PN: 33.1 +/- 12.3 years
- ON: 36.7 +/- 12.1 years
Ethnicity:
- Not Specified
Other relevant demographics:
Diagnosis:
- AML (n=7): PN n=3; ON n=4
- ALL (n=2): PN n=2; ON n=0
- Hodgkin's Ds (n=9): PN n=4; ON n=5
- NHL (n=17): PN n=10; ON n=7
Anthropometrics
Parenteral Group | Oral Group | |
Women | ||
Weight (kg) | 61.5±13.7 | 70.6±18.1 |
Fat Mass (%) | 24.9±11.7 | 32.2±7.0 |
LBM (%) | 75.1±1.7 | 67.8±6.9 |
Body Water (%) | 54.9±8.5 | 49.6±5.1 |
Men | ||
Weight (kg) | 77.3±13.7 | 85.3±14.6 |
Fat Mass (%) | 20.1±10.7 | 23.5±5.9 |
LBM (%) | 79.8±10.7 | 76.5±5.9 |
Body Water (%) | 58.9±7.8 | 56.1±4.3 |
Parenteral Group
Oral Group
Women
Weight (kg)
69.4±15.6
74.3±18.1
BMI
23.6±4.9
26.4±4.2
Albumin (g/L)
41.6±4.8
41.6±3.3
Total Protein (g/L)
68.9±7.8
68.0±6.9
Location:
- The Hematology Clinic of the Jagiellonian University Collegium Medicum in Krakow, Poland
- PN required by 19 subjects (7 women, 12 men); 16 subjects (12 women, 4 men) fed orally
- PN started (average) post-transplant day-5
- PN contiuned 9.4 ± 2.8 days
- Baseline Nutrition Status
- No significant differences in BMI between groups at baseline
- Lower fat mass, higher LBM and body water in PN group
- Post-Transplant
- Decrease in BMI, weight, and fat mass in both groups, no statistical difference between groups
- Decrease in albumin in both groups, no statistical difference between groups
|
Parenteral Group
|
Oral Nutrition Group
|
Statistical Significance of Group Difference
|
Body Mass
|
|||
Baseline
|
69.4±15.6
|
74.3±18.1
|
NS
|
Timepoint II
|
67.9±14.9
|
72.3 ±17.8
|
NS
|
Timepoint III
|
67.4±14.7
|
71.2±17.4
|
NS
|
Timepoint IV
|
64.9±14.3
|
70.2±17.5
|
p<0.05
|
BMI
|
|||
Baseline
|
23.6±4.9
|
26.4±4.2
|
NS
|
Timepoint II
|
23.0±4.8
|
25.6±4.1
|
NS
|
Timepoint III
|
22.9±4.8
|
25.2±3.9
|
NS
|
Timepoint IV
|
22.0±4.6
|
24.9±4.1
|
NS
|
Albumin (g/L)
|
|||
Baseline
|
41.6±4.8
|
41.6±3.3
|
NS
|
Timepoint II
|
39.1±4.1
|
39.9±3.5
|
NS
|
Timepoint III
|
37.5±5.6
|
38.8±3.9
|
NS
|
Timepoint IV
|
40.1±4.8
|
41.1±3.8
|
NS
|
Total Protein (g/L)
|
|||
Baseline
|
68.9±7.8
|
68.0±6.9
|
NS
|
Timepoint II
|
63.4±6.8
|
65.3±6.8
|
NS
|
Timepoint III
|
64.0±8.1
|
65.1±6.3
|
NS
|
Timepoint IV
|
65.3±6.4
|
67.9±6.4
|
NS
|
Other Findings
- 5 patients in the PN group continued oral intake at 3-5 Kcal/kg/day and 0.1-0.2g protein/kg/day
- Pyrexia and infection more common in PN group, but not statistically significant
Parenteral nutrition supplying 25-30 Kcal/kg and 1.0-1.5g protein/kg maintained body mass and the functions of the hematopoietic system similar to oral and enteral feeding.
The following limit the applicability of the article:
- Small number of patients in each group
- No discussion of actual nutrients consumed in comparison to needs
- No assessment of the appropriateness of needs calculations
- Data on 24-hour Nitrogen not presented
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 | |
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 | |
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 | |
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 | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
Validity Questions | |||
1. | Was the research question clearly stated? | 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 | |
1.1. | 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 | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | 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? | No | |
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? | No | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
3. | Were study groups comparable? | 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 | |
3.1. | 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 | |
3.2. | 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 | |
3.3. | 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 | |
3.4. | 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 | |
3.5. | 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 | |
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? | No | |
4. | Was method of handling withdrawals described? | No | |
4.1. | Were follow-up methods described and the same for all groups? | 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%.) | No | |
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%.) | No | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.4. | Were reasons for withdrawals similar across groups? | ??? | |
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? | 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? | No | |
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? | No | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | No | |
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.) | No | |
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.) | No | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | 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 | |
5.4. | 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 | |
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? | No | |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | No | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | 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 | |
6.2. | 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 | |
6.3. | 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? | No | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | No | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
6.6. | Were extra or unplanned treatments described? | No | |
6.6. | Were extra or unplanned treatments described? | No | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | 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 | |
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. | 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 | |
7.1. | 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 | |
7.2. | 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 | |
7.3. | 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 | |
7.4. | 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 | |
7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.7. | Were the measurements conducted consistently across groups? | 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. | 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 | |
8.1. | 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 | |
8.2. | 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 | |
8.3. | 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)? | ??? | |
8.4. | 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)? | No | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | No | |
8.6. | Was clinical significance as well as statistical significance reported? | No | |
8.6. | Was clinical significance as well as statistical significance reported? | No | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
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? | No | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | No | |
9.1. | Is there a discussion of findings? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.2. | Are biases and study limitations identified and discussed? | No | |
9.2. | Are biases and study limitations identified and discussed? | No | |
10. | Is bias due to study's funding or sponsorship unlikely? | No | |
10. | Is bias due to study's funding or sponsorship unlikely? | No | |
10.1. | Were sources of funding and investigators' affiliations described? | No | |
10.1. | Were sources of funding and investigators' affiliations described? | No | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |