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Severe MalnutritionNCT03484481

Incomes of Nutritional Support Modalities in Hemodialysis Patients With Severe Malnutrition

An observational study of Severe Malnutrition, run by Baskent University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Malnutrition
What is being tested?
Oral Nutritional Support; Nutrena and Intradialytic Parenteral Nutrition; Kabiven central
How many people
56 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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 )

Who cannot join

  • 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;
Show all 9Show fewer
  • hospitalization at time of randomization
  • nephrotic syndrome
  • active malignancy or history of malignancy.

About this study

Official title: Positive Incomes of Nutritional Support Modalities in Terms of Nutritional Status and Inflammation in Hemodialysis Patients With Severe Malnutrition

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).

Read the detailed description

Our current standard nutrition care is based upon existing recommendations and involves nutrition counselling for optimal dietary intake from food and beverages, food fortification, administration of oral nutrition supplementation (ONS) and/or IDPN in malnourished MHD patients.

Among 712 MHD patients, 138 who were diagnosed as severely malnourished (subjective global assessment (SGA) scores are B/C and serum albumin concentration <3.5 g/dL and/or a loss of ≥5% dry weight (DW) over the past 3 months ) were followed up between January 2016 - December 2016.

The patients whose at least 6 months interrupted data could be obtained under the recomemded nutritional support were included. Exclusion criteria were as follows; active infectious disease, chronic inflammatory systemic diseases (CIDs) like rheumatoid arthritis, systemic lupus erythematosus and multiple sclerosis, malabsorption syndrome, those treated with steroids or antiandrogens, 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.

eigthy-two patients were excluded according to above criteria thus 56 severely malnourished patients data was included to the study and are recommended 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.

Patients were distributed into 4 groups according to patients requests for nutritional support modalities. We offered the combination of ONS and 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) (Figure 1: Study Flowchart).

All patients gave informed consent for this study, which was approved by the ethics committee of Baskent University School of Medicine.

Nutritional supplementation Each patient was consulted monthly by a dietitian to achieve the target calorie intake of 35 kcal/kg/day. A snack providing approximately 300 kcal, 14 g protein, 55 g carbohydrate, and 10 g fat was served to all patients during the sessions.

  • Oral Nutrition Support (ONS): Patients in group 1 and 3 take ONS 200 ml/day twice a day at home. Each serving (200 mL) of ONS preparation (Nutrena;Abbott Nutrition, Zwolle, Holland) contained 400 kcal, 14 g protein, 41.3 g carbohydrate, and 19.2 g fat and had lower concentrations of sodium, potassium, and phosphorus than standard ONS. ONS consumption was recorded at each dialysis session.
  • Intradialytic Parenteral Nutrition (IDPN) Patients in group 2 and 3 received IDPN administrations [(Kabiven central; a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag; the solution contains dextrose solution for fluid replenishment and caloric supply amino acid solution with electrolytes, which comprises essential and nonessential amino acids provided with electrolytes and Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids]. 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.
Being tested
Oral Nutritional Support; Nutrena, Intradialytic Parenteral Nutrition; Kabiven central
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Nutritional Support; NutrenaDietary 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.

  • Intradialytic Parenteral Nutrition; Kabiven centralDietary 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.

Study groups in NCT03484481
Study groupRoleWhat they receive
1;Oral nutritional support (ONS)patients ongoing hemodialysis who received only oral nutritional support (Nutrena) and refused intradialytic parenteral nutrition; n: 14
Receives: Dietary Supplement: Oral Nutritional Support; Nutrena
2; Intradialytic Parenteral Nutritionpatients ongoing hemodialysis who received only Intradialytic Parenteral Nutrition (Kabiven central) and refused parenteral nutrition; n: 14
group 3; combination grouppatients ongoing hemodialysis received both ONS and Intradialytic Parenteral Nutrition NS; n: 10
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammation

    C-reactive protein

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484481
Sponsor's protocol ID
3558238bc
Status last verified
Mar 2018
First submitted
24 Mar 2018
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Malnutrition, run by Baskent University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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