MedTrace Logo

Incomes of Nutritional Support Modalities in Hemodialysis Patients With Severe Malnutrition

NCT03484481 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2018-04-03

No results posted yet for this study

Summary

Introduction: Protein energy malnutrition is one of the strongest predictors of morbidity and mortality in maintenance hemodialysis (MHD) patients. Many reports indicate that there is a high prevalence of malnutrition up to 40% , and has a strong association with inflammation and cardiovascular disease (CVD) as well as lower quality of life in this population. The aim of this study was to compare the nutritional modalities by means of biochemical parameters, arterial stiffness and bioimpedance analysis.

Material and Methods: We designed an observational study with 56 malnourished MHD patients (mean age: 61.8±12.3 years, duration of hemodialysis: 7.9±5.1 years) . Patients were distributed into 4 groups according to patients requests for nutritional support modalities. We offered the combination of oral nutritional support (ONS) and intradialytic parenteral nutrition (IDPN) to all patients however some of the patients refused this combination thus we had 4 groups as; Group 1 (patients received only ONS and refused parenteral nutrition; n: 14), group 2 (patients received only parenteral NS and refused ONS; n: 14), group 3 (patients received both oral and parenteral NS; n: 10) and group 4 (dietetic support group; patients who refused all types of nutritional support and only followed by counselling, n: 18) for 12 months. Biochemical parameters were assessed from monthly clinical visits. Normalized protein catabolic rate (nPCR), malnutrition-inflammation score (MIS), body composition (fat mass \[FM\], fat-free mass (FFM) muscle mass (MM, body mass index (BMI)) by multifrequency bioimpedance analysis (BCM, Fresenius).

Conditions

  • Severe Malnutrition

Interventions

DIETARY_SUPPLEMENT

Oral Nutritional Support; Nutrena

Patients in group 1 and 3 take ONS 200 ml/day twice a day at home. Patients in group 2 and 3 received IDPN administrations. \]. Its infusion was started 30 minutes after initiation of HD via the venous port of the bubble trap on the HD tubing and continued throughout the entire HD procedure at a rate of 150 ml/h for 30 min and consisted of 300 ml for 3 hour.

DIETARY_SUPPLEMENT

Intradialytic Parenteral Nutrition; Kabiven central

Patients in group 2 and 3 received IDPN administrations Its infusion was started 30 minutes after initiation of HD via the venous port of the bubble trap on the HD tubing and continued throughout the entire HD procedure at a rate of 150 ml/h for 30 min and consisted of 300 ml for 3 hour.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484481 on ClinicalTrials.gov