Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3

Conditions: Chronic Kidney Failure

Treatments: Drug: Testosterone; Other: training on ergonomic bicycle; Drug: n3 polyunsaturated fatty acid; Drug: Oral nutritional supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02418065

CHU-0231

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

treated group

Experimental group

Description:

testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle

Treatment:

Other: training on ergonomic bicycle

Drug: Oral nutritional supplementation

Drug: Testosterone

Drug: n3 polyunsaturated fatty acid

control group

Other group

Description:

oral nutritional supplementation

Treatment:

Drug: Oral nutritional supplementation