EAL

HF: Sodium and Fluid (2016)

Author and Year:

Paterna et al, 2011

PubMed ID:

Article Title:

Short-term effects of hypertonic saline solution in acute heart failure and long-term effects of a moderate sodium restriction in patients with compensated heart failure with New York Heart Association class III (Class C) (SMAC-HF Study).

Authors:

Paterna S,Fasullo S,Parrinello G,Cannizzaro S,Basile I,Vitrano G,Terrazzino G,Maringhini G,Ganci F,Scalzo S,Sarullo F,Cice G,Di Pasquale P

Journal:

The American journal of the medical sciences

Year of publication:

2011

Volume:

342

Issue:

Page numbers:

27-37

Study Design:

Randomized Controlled Trial

Risk of Bias Assessment Rating:

Positive

Inclusion Criteria:

decompensated HF by chronic ischemic or nonischemic cardiomyopathy, older than18 years and, according to HF definition,1 Framingham criteria and New York association functional classification for HF,2 uncompensated HF (dyspnoea, weakness and lower limb edema), in NYHA III functional class, that was unresponsive to treatment with oral high doses of furosemide up to 250 mg/d, spironolactone, angiotensin-converting enzyme (ACE) inhibitors, digitalis and nitrates; moreover, they had to be under this therapy at least 4 weeks before the study and before hospitalization. The patients were judged unresponsive when they showed, during the aforementioned treatment, a reduction of urine volume, a constant increase of body weight (BW) and an impairment of clinical HF as reported above, despite the increase of furosemide. In addition, they had to have a left ventricular ejection fraction (EF) 40%, serum creatinine 2.5 mg/dL, blood urea nitrogen (BUN) 60 mg/dL and a reduced urina

Exclusion Criteria:

Patients with NYHA class III or III on admission or with NYHA class III at discharge,with concomitant main comorbidities, as cerebral vascular disease, dementia, cancer, uncompensated diabetes, severe hepatic disease and inability to give informed consent were excluded, as were patients requiring pacemaker implantation and those with an alcoholic habit. Patients were also excluded if they declined to take part in the study protocol. Moreover, patients with side effects for ACE inhibitor treatment (cough), even if these patients were given angiotensin 2-receptor blockers to obtain treatments as homogeneous as possible treatment, were also excluded. In addition, patients who did not follow the assigned treatment, did not attend the scheduled clinical visits, did not adhere to prescribed diet and the fluid intake of 1000 mL/day or had a reduction or discontinuation of prescribed treatments during follow up were excluded from the study

Research Purpose:

the effects of the combination of HSS/high doses of furosemide/moderate Na restriction on hospitalization time compared with no HSS/high doses of furosemide/low Na diet combination in patients in III New York Heart Association (NYHA) class and/or stage C (moderate limitation symptoms noted with minimal activity—past or current HF symptoms in association with structural damage to the heart) and the effects of moderate furosemide oral doses/moderate Na restriction versus moderate furosemide oral doses/low Na diet on readmissions and mortality due to cardiac causes in the long term.

Blinding efforts:

single blind as suggested by ethical committee;the patients were blinded about the administered treatments

Study Location:

Italy

Source(s) of Funding:

Not reported

Please specify names of funders:

Not reported

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?	No
	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?	No
	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?	Yes
	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
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?		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)?	Yes
	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?	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?	No
	10.2.	Was the study free from apparent conflict of interest?	???