EAL

CKD: Protein Energy Supplements: Dialysate (2018)

Author and Year:

Jones M et al 1998

PubMed ID:

9820445

Article Title:

Treatment of malnutrition with 1.1% amino acid peritoneal dialysis solution: results of a multicenter outpatient study.

Authors:

Jones M, Hagen T, Boyle C, Vonesh E, Hamburger R, Charytan C, Sandroni S, Bernard D, Piraino B, Schreiber M, Gehr T, Fein P ,Friedlander M, Burkart J, Ross D, Zimmerman S, Swartz R, Knight T, Kraus A, McDonald L, Hartnett M, Weaver M, Martis L, Moran J

Journal:

American Journal of Kidney Diseases : the official journal of the National Kidney Foundation

Year of publication:

1998

Volume:

Issue:

Page numbers:

761-9

Study Design:

Randomized Controlled Trial

Risk of Bias Assessment Rating:

Neutral

Inclusion Criteria:

To be considered for participation in the study, patients had to be between the ages of legal consent and 75 years and be adequately dialyzed, stable patients with a history of good compliance with therapy who had been treated with peritoneal dialysis for at least 4 months before study entry. They had to score greater than 60 on the Karnofsky Scale of Activity and be able to tolerate 2-L exchange volumes. To be eligible for the study, patients had to meet at least 2 of the following 3 criteria: (1) daily dietary protein intake estimated from urea nitrogen appearance using the Randerson equation of 1.0 g per kg ideal body weight or less (desirable body weight in the 1983 Metropolitan Life Tables for a person of the same sex and frame size); (2) serum albumin level (measured by bromcresol green method) of 3.7 g/dL or less for men and 3.5 g/dL or less for women; and/or (3) evidence of malnutrition based on the Subjective Global Assessment.

Exclusion Criteria:

Patients were excluded from participation if they had any of the following conditions: (1) more than one episode of peritonitis in the past 6 months, one or more episodes within 1 month before the study, or incomplete recovery from the effects of previous peritonitis at the time of entering the study; (2) associated diseases or medications that could have led to a catabolic state; (3) illness requiring hospitalization within 30 days before the study; (4) evidence of malignancy; (5) likely to receive a kidney transplant within the time of the study; (6) requirement for potassium supplementation or other routine medications (with the exception of insulin or occasional heparin) into the dialysis solution container; (7) participation in another study that would interfere with the outcome of this study; or (8) seropositive for hepatitis B or, if tested, hepatitis C or HIV.

Research Purpose:

To evaluate the effect of a peritoneal dialysis solution containing 1.1% amino acids for 3 months on malnutrition in malnourished peritoneal dialysis patients.

Blinding efforts:

Not reported

Study Location:

18 Centers in the United States

Source(s) of Funding:

Industry

Please specify names of funders:

Supported in part by the Renal Division of Baxter Healthcare Corporation, the manufacturers of the dialysates.

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?		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?		No
	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?	No
	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?	No
	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
7.	Were outcomes clearly defined and the measurements valid and reliable?		???
	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?	???
	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?	No
	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)?	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	???