Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Human Nutrition Research Center Rhône-Alpes; NUTRICIA; Nutricia, Inc.; Société Francophone Nutrition Clinique et Métabolisme
• Treatments: Testosterone

Criteria

Inclusion Criteria:

• Hemodialysis patient since at least 6 month

• Patient aged 18 years or older

• Written consent to participate in the study

• No acute infection or hospitalization

• Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity

• Protein-energy wasting diagnosed if at least two of this characteristics are present

• Serum albumin <3.8 g per 100 ml (Bromcresol Green)

• Serum prealbumin (transthyretin) <30mg per 100 ml

• Reduce body mass (BMI <23)

• Unintentional 10% weight loss over 6 months

• Lean body mass index < 10th percentile

Exclusion Criteria:

• Presence of comorbidity which compromising the survival within 6 month

• Unintentional low DEI <20 kcal kg_1 day_1

• HIV or HCV positive

• History of hormone dependent cancer

• Suspected or confirmed prostate cancer or breast carcinoma

• Known hypersensitivity for testosterone

• Presence or history of hepatic tumor

• Inability to follow the rehabilitation program

• Inadequate dialysis dosage (<12 hours / week or Kt/V index< 1,2) Pregnant or planning pregnancy and lactating women during study period

• Adult patient protected by law

• Patient who don't sign his informed consent