Incomes of Nutritional Support Modalities in Hemodialysis Patients With Severe Malnutrition

NCT03484481 | Completed

• 1 other identifier: 3558238bc
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Inflammation

  C-reactive protein

  12 months

Study Arms (4)

1;Oral nutritional support (ONS)

patients ongoing hemodialysis who received only oral nutritional support (Nutrena) and refused intradialytic parenteral nutrition; n: 14

Dietary Supplement: Oral Nutritional Support; Nutrena

2; Intradialytic Parenteral Nutrition

patients ongoing hemodialysis who received only Intradialytic Parenteral Nutrition (Kabiven central) and refused parenteral nutrition; n: 14

group 3; combination group

patients ongoing hemodialysis received both ONS and Intradialytic Parenteral Nutrition NS; n: 10

Dietary Supplement: Oral Nutritional Support; Nutrena; Dietary Supplement: Intradialytic Parenteral Nutrition; Kabiven central

group 4; dietetic support group;

patients ongoing hemodialysis who refused all types of nutritional support and only followed by counselling, n: 18

Interventions

Oral Nutritional Support; Nutrena DIETARY_SUPPLEMENT

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.

1;Oral nutritional support (ONS); group 3; combination group

Intradialytic Parenteral Nutrition; Kabiven central DIETARY_SUPPLEMENT

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.

group 3; combination group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Among 712 MHD patients, 138 who were diagnosed as severely malnourished were followed up between January 2016 - December 2016. Eigthy-two patients were excluded according to above criteria thus 56 severely malnourished patients data was included to the study and are recomended to receive ONS and/or IDPN. The given supplementation is continued until the nutritional parameters are ameliorated. The patients choice was the determinator of the received nutritional support.

You may qualify if:

• subjective global assessment (SGA) scores B or C
• serum albumin concentration \<3.5 g/dL
• loss of ≥5% dry weight (DW) over the past 3 months )

You may not qualify if:

• active infectious disease,
• chronic inflammatory systemic diseases (CIDs) like rheumatoid arthritis, systemic lupus erythematosus
• multiple sclerosis
• malabsorption syndrome
• inadequate dialysis (single pool Kt/V \< 1.4)
• recent surgery within 3 months or during follow-up;
• hospitalization at time of randomization
• nephrotic syndrome
• active malignancy or history of malignancy.

Sponsors & Collaborators

• Baskent University: lead

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: March 30, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 3, 2018

Record last verified: 2018-03