Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial Comparing, in Fluid-Overloaded Hemodialysis Patients, Three Strategies of Fluid Removal: Regulation of Ultrafiltration and Dialysate Conductivity, Regulation of Ultrafiltration and Temperature, and Standard Hemodialysis
Brief Summary: Background: Data generated with the body composition monitor (BCM, Fresenius) show based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood-volume monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid overloaded hemodialysis patients.

Methods/Design: BCM-measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel group, cross-over, randomized, controlled clinical trial, we use BCM-measurements, routinely introduced in our 3 maintenance hemodialysis centers shortly prior to the start of the study, to recruit 60 hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final' dry weight is set as -7% ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a pre-specified algorithm. A comparison of intra- and postdialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters).

Discussion: Patients are not requested to revert to their initial degree of fluid overload after each study phase, Therefore, the cross-over design of the present study merely serves the purpose of secondary end-point evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management which decreases the mortality risk of hemodialysis patients.


Options:
A: Inclusion Criteria:

* HD \>3 months
* Fluid overload ≥15% of extracellular volume (ECV) predialysis, as determined by BCM-measurement, after one of the 2 the midweek interdialytic intervals
* Informed consent of the patient

Exclusion Criteria:

* none, except those specified by the Declaration of Helsinki
B: Inclusion Criteria:

* Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
* Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
* Hemoglobin level ≥ 9g/dL;
* Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
* To understand and sign an informed consent form.

Exclusion Criteria:

* History of alcohol or drug abuse in the last six months before selection for the study;
* Androgen therapy in the last six months before selection;
* Active infections;
* History of congestive heart failure stage III and IV New York Heart Association (NYHA);
* History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
* Clinically relevant cardiac arrhythmia;
* Clinically relevant abnormalities of functional hepatic tests;
* Therapy with L-carnitine or its derivatives in the last three months before selection;
* Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
* Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
* Participation in another clinical study within the past month;
* Known allergic reactions to L-carnitine or xylitol.
C: Inclusion Criteria:

* Patient with less than 1 month on hemodialysis.
* Treated with rHuEPO.
* Male or female aged of more than 18 years old.
* With contraception treatment for women of procreation age.
* Having received and understand information.

Exclusion Criteria:

* Patients with no need of rHuEPO
* Patients with cancer disease
* Patients with life expectancy under 6 months
* Patients having a proved carnitine deficiency before the start of hemodialysis
D: Inclusion Criteria:

* Adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion.
* At least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
* Standard hemodialysis therapy (3 days/week, 240 min, high permeability dialyzer, blood flow \>250 ml/min and dialysate flow 500 ml/min) or on-line hemodialysis therapy that was not modified in the last 3 months previous to the inclusion.
* Written informed consent obtained.

Exclusion Criteria:

* Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c\>9%.
* Unstable dry weight.
* Limb amputation.
* Significant edema.
* Active malignancy.
* Hospital admissions in the last 3 months.
* Acute gastrointestinal disease in the 2 weeks before the inclusion.
* Gastrectomy, gastroparesis or abnormal gastric emptying.
* Acute heart failure grade IV.
* Severe hepatic insufficiency (men gamma glutamyl transferase -GGT- \>150 U/l, women \>120 U/l).
* Alcohol or other drugs abuse.
* Participants enrolled in other research study at inclusion.
* Pregnant women.
* No informed consent obtained.
* Patients who received any oral nutritional supplement (specific for hemodialysis patients or not) in the 4 weeks before the inclusion.
* Patients receiving enteral tube feeding.
* Galactosemia, fructosemia, or requirement of a no fiber diet.
* Allergy or hypersensitivity to any ingredient of the oral nutritional supplement.
* Ongoing treatment with glucocorticoids.
* Patients who received any oral fatty acids omega-3 supplement in the 4 weeks before the inclusion.
* Patients who received intradialytic parenteral nutrition in the 3 months before the inclusion.
* Patients who received any probiotics or prebiotics (not as part of the diet) in the 3 months before the inclusion.
* Anemia (Hemoglobin \< 10 g/dl) or Epoetin resistance.

Answer: A