Malnutrition-Inflammation SyndromeNCT01214447
Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
An observational study of Malnutrition-Inflammation Syndrome and Hemodialysis Nutritional Risk Stratification, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition-Inflammation Syndrome, Hemodialysis Nutritional Risk Stratification
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Dec 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 300 stable chronic hemodialysis patients receiving maintenance hemodialysis treatment in our dialysis unit (nephrology division, Assaf Harofeh Medical Center) and in 2 satellite hemodialysis units (Nephromor, Rishon Lezion and Afek, Ramla).
Who may be able to join
- Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
- Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly
- Patients with normal hydration status (edema-free), with no neuroid-muscular diseases
- Informed consent obtained before any trial-related activities
Who cannot join
- Patients with edema, pleural effusion or ascites at their initial assessment
- Patients with active malignant disease or liver cirrhosis
- Patients with neuroid-muscular diseases
- Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
- Patients treated with immunosuppressive agents
- Patients suffering from
Show all 9Show fewer
- Acute vasculitis
- Severe systemic infections
- Heart failure (NYHA class III-IV)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tsrifin, 70300
Ilia Beberashvili, MD
Ada Azar, BSc
About this study
This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse combinations. The investigators specific aim is to validate OSND in chronic HD patients by comparing it with conventional measures of nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance analysis and several measures of clinical outcome including prospective mortality and hospitalization.
- Being tested
- No intervention
- Keywords
- Hemodialysis, Inflammation, Malnutrition, Phase Angle
- Medical subject headings
- Inflammation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study - no intervention
| Study group | Role | What they receive |
|---|---|---|
| Low - OSND less than 22 | Not described Receives: Other: No intervention | |
| Moderate - OSND score 23-27 | Not described Receives: Other: No intervention | |
| Normal - OSND score 28-32 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause morbidity and mortality
- Associations of OSND with:
- Morbidity: Days at hospital (over night stay). Measured from baseline to end of study
- Morbidity: Number of sick days during the study period
- Morbidity: Number of visits to health care professionals other than hospitals
- Mortality: From baseline visit to end of study
- Interobserver reproducibility of OSND.
Measured: during 2 years of observation
Secondary outcomes (1)
All cause morbidity and mortality
Associations of MIS, GNRI and phase angle with:
- Morbidity: Days at hospital (over night stay). Measured from baseline to end of study
- Morbidity: Number of sick days during the study period
- Morbidity: Number of visits to health care professionals other than hospitals
- Mortality: From baseline visit to end of study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition-Inflammation SyndromeStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Ilia Beberashvili, MD, Principal investigator, Nephrology division Assaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214447
- Sponsor's protocol ID
- 132/10
- Status last verified
- Sep 2010
- First submitted
- 3 Oct 2010
- Last updated
- 5 Oct 2010
- Results posted
- No
Publications
Beberashvili I, Azar A, Sinuani I, Yasur H, Feldman L, Averbukh Z, Weissgarten J. Objective Score of Nutrition on Dialysis (OSND) as an alternative for the malnutrition-inflammation score in assessment of nutritional risk of haemodialysis patients. Nephrol Dial Transplant. 2010 Aug;25(8):2662-71. doi: 10.1093/ndt/gfq031. Epub 2010 Feb 26.
PubMed 20190238
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT01214447
- Acronym / sponsor ID
- 132/10
- Keywords
- Hemodialysis, Inflammation, Malnutrition, Phase Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Oct 2010 (estimated)
- 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.
This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse combinations. The investigators specific aim is to validate OSND in chronic HD patients by comparing it with conventional measures of nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance analysis and several measures of clinical outcome including prospective mortality and hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low - OSND less than 22 | – | Other: No intervention |
| Moderate - OSND score 23-27 | – | Other: No intervention |
| Normal - OSND score 28-32 | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 stable chronic hemodialysis patients receiving maintenance hemodialysis treatment in our dialysis unit (nephrology division, Assaf Harofeh Medical Center) and in 2 satellite hemodialysis units (Nephromor, Rishon Lezion and Afek, Ramla).
Key inclusion criteria (4 listed)
- Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
- Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly
- Patients with normal hydration status (edema-free), with no neuroid-muscular diseases
- Informed consent obtained before any trial-related activities
Key exclusion criteria (9 listed)
- Patients with edema, pleural effusion or ascites at their initial assessment
- Patients with active malignant disease or liver cirrhosis
- Patients with neuroid-muscular diseases
- Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
- Patients treated with immunosuppressive agents
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 |
|---|---|---|
| No interventionObservational study - no intervention | Other | Low - OSND less than 22, Moderate - OSND score 23-27, Normal - OSND score 28-32 |
Primary outcome
All cause morbidity and mortality
Time frame: during 2 years of observation
* Associations of OSND with: * Morbidity: Days at hospital (over night stay). Measured from baseline to end of study * Morbidity: Number of sick days during the study period * Morbidity: Number of visits to health care professionals other than hospitals * Mortality: From baseline visit to end of study * Interobserver reproducibility of OSND.
1 secondary outcome
All cause morbidity and mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Background: PubMed 20190238Beberashvili I, Azar A, Sinuani I, Yasur H, Feldman L, Averbukh Z, Weissgarten J. Objective Score of Nutrition on Dialysis (OSND) as an alternative for the malnutrition-inflammation score in assessment of nutritional risk of haemodialysis patients. Nephrol Dial Transplant. 2010 Aug;25(8):2662-71. doi: 10.1093/ndt/gfq031. Epub 2010 Feb 26.
Related trials for Malnutrition-Inflammation Syndrome
RecruitingPhase 1/2
Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients
Kidney Failure, Chronic, Malnutrition-Inflammation Syndrome
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.
Ilia Beberashvili, MD principal investigator
Nephrology division Assaf Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition-Inflammation Syndrome and Hemodialysis Nutritional Risk Stratification, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilia Beberashvili, MD (+97289779383, iliab@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause morbidity and mortality (time frame: during 2 years of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214447, which also lists 1 linked publication.
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 5 Oct 2010; AzTrials last refreshed its copy on 8 Nov 2026.