Severe MalnutritionNCT03484481
Incomes of Nutritional Support Modalities in Hemodialysis Patients With Severe Malnutrition
An observational study of Severe Malnutrition, run by Baskent University.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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;
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- 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.
- Conditions
- Severe Malnutrition
- 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 group | Role | What 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 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 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.
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.
- First posted30 Mar 2018
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Gurlek Demirci, Baskent University
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Incomes of Nutritional Support Modalities in Terms of Nutritional Status and Inflammation in Hemodialysis Patients With Severe Malnutrition
- ClinicalTrials.gov ID
- NCT03484481
- Acronym / sponsor ID
- 3558238bc
- Conditions
- Severe Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1;Oral nutritional support (ONS) | – | Dietary Supplement: Oral Nutritional Support; Nutrenapatients ongoing hemodialysis who received only oral nutritional support (Nutrena) and refused intradialytic parenteral nutrition; n: 14 |
| 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 | – | Dietary Supplement: Oral Nutritional Support; Nutrena, Dietary Supplement: Intradialytic Parenteral Nutrition; Kabiven centralpatients ongoing hemodialysis received both ONS and Intradialytic Parenteral Nutrition NS; n: 10 |
| group 4; dietetic support group; | – | –patients ongoing hemodialysis who refused all types of nutritional support and only followed by counselling, n: 18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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 )
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Support; NutrenaPatients 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 | 1;Oral nutritional support (ONS), group 3; combination group |
| Intradialytic Parenteral Nutrition; Kabiven centralPatients 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 | group 3; combination group |
Primary outcome
Inflammation
Time frame: 12 months
C-reactive protein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.