CKD: Protein Energy Supplements: Dialysate (2018)
Author and Year:
Li F et al 2003
PubMed ID:
Article Title:
A 3-year, prospective, randomized, controlled study on amino acid dialysate in patients on CAPD.
Authors:
Li F, Chan L, Woo J, Ho S, Lo W, Lai K, Chan T
Journal:
American Journal of Kidney Diseases : the official journal of the National Kidney Foundation
Year of publication:
2003
Volume:
42
Issue:
1
Page numbers:
173-83
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Neutral
Inclusion Criteria:
Inclusion criteria of patients included age between 18 and 75 treated with peritoneal dialysis for at least 6 months, residual urine less than 200 mL/d, written informed consent, Kt/V greater than
1.7, the ability to be dialyzed with 2-L exchanges, and at least 2 of the following: (1) protein nitrogen intake of less than 0.9 g/kg of ideal body weight estimated from urea nitrogen appearance using the equation from Bergstrom, (2) serum albumin level less than 3.5 g/dL (35 g/L), or (3) evidence of malnutrition based on Subjective Global Assessment (SGA).
Exclusion Criteria:
Patients were excluded if they had any 1 of the following conditions: (1) more than 1 episode of peritonitis in the last 6 months; (2) peritonitis or hospitalization within 1 month; (3) concomitant disease or medication that could have led to a catabolic state; (4) likelihood to receive a kidney transplant within the study period; or (5) infected with hepatitis B, C, or human immunodeficiency virus (HIV). Lipid-lowering agents, eg, statins and fibrates, or drugs which had a direct pharmacological effect on the serum lipid level were avoided during the study.
Research Purpose:
To investigate the long-term impact of amino acid dialysate on the nutritional status, peritoneal transport function, and clinical outcome of malnourished Chinese patients on continuous ambulatory peritoneal dialysis (CAPD).
Blinding efforts:
Not Reported
Study Location:
Queen Mary Hospital and Tung Wah Hospital, Hong Kong, China
Source(s) of Funding:
Industry, University/Hospital
Please specify names of funders:
Queen Mary Hospital and Tung Wah Hospital, Hong Kong, China. This study was supported by the Baxter Extramural Grant Program (the manufacturer of the dialysates) and the Nephrology Fund of the University of Hong Kong.
Quality Criteria Checklist: Primary Research
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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? | ??? | |
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? | ??? | |
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) | 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 | |
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 | |
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? | 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.) | Yes | |
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 | |
6.3. | 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 | |
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? | ??? | |
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? | ??? | |
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)? | No | |
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? | 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? | ??? | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |