The effect of intradialytic parenteral nutrition on nutritional status and quality of life in hemodialysis patients
Recruiting
- Conditions
- dialysemalnutritionsarcopenia1000301810038430
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 166
Inclusion Criteria
- Age: >= 18 years
- Hemodialysis, 3 times / week, minimum 3,5 hours / session.
Exclusion Criteria
- Life expectancy < 6 months
- Planned kidney transplant within 4 months
- Active treatment for infection
- Pregnancy
- Parenteral nutrition for at least four weeks prior to screening
- Unipolar pacemaker with a very low sensitivity threshold
- Regular exclusion criteria for the use of parenteral nutrition in
hemodialysis patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To analyze the change in lean tissue Mass (LTM) assessed by Body Composition<br /><br>Monitor (BCM).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To analyze the change in:<br /><br><br /><br>- Adipose Tissue Mass (ATM) assessed by Body Composition Monitior (BCM)<br /><br>- Body weight<br /><br>- Target weight<br /><br>- Functionality assessed by hand grip strenght (HGS)<br /><br>- Appetite (NRS)<br /><br>- Muscle health index assessed by ultrasound<br /><br>- Subjective Global Assessment (SGA), 7 point scale<br /><br>- Food intake assessed by 24-hours recall with global dietary history (calories<br /><br>and protein)<br /><br>- Exercise, assessed by Activ8 and exercise dairy<br /><br>- Quality of Life: assessed by KDQoL and PANAS<br /><br>- KT/V<br /><br>- (n)PCR<br /><br>- Serum CRP<br /><br>- Serum albumin<br /><br>- Serum pre-albumin<br /><br>- Serum bicarbonate<br /><br>- Phase Angel, assessed by Body Composition Monitor (BCM)<br /><br>• Changes in hormones<br /><br>• Hospital admission</p><br>