MalnutritionHemodialysisNCT01042405
Nutrition Based Computerized Predictive Method for Morbidity & Mortality Risk in HD Patients. Assisng NIR for Blood Cr
An observational study of Malnutrition and Inflammation, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to develop a simple computer program, evaluating nutritional status of HD patients. The programming will enable to perform a nutritional screening, based on biochemical measures, taken as part of HD patients' routine care every month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Inflammation, Morbidity
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Oct 2021
- 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: patients on hemodialysis, Wolfson Hospital
Who may be able to join
- All dialysis patients in Wolfson Medical Center dialysis unit above the age of 18 years and on dialysis more than 3 months.
Who cannot join
- Patients with bilateral plegia. Hemiplegic organs of a patient (not the entire patient).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Zvi Barnea, MD
About this study
Official title: Development of a Risk Computerized Predictive Method in HD Patients by Nutritional Scoring & Assesment of NIR Method for Cr Determination
The aim of the study is to develop a simple computer program, evaluating nutritional status of HD patients. The programming will enable to perform a nutritional screening, based on biochemical measures, taken as part of HD patients' routine care every month. The program will identify patients at risk of malnutrition, define the degree of malnutrition, and identify patients who at risk for increased morbidity and mortality. Patients who are at risk of malnutrition will be treated by a standard nutrition; dietary counseling (high protein diet, appropriate calories intake and use of oral supplementation. Intra-dialytic parenteral nutrition (IDPN) will be used for patients who fail to improve nutrition status by standard nutrition care, as a second line treatment. The effect of IDPN on their nutrition status will be evaluated. A sub group of 30 patients will provide blood smample to assess a NIR method for Cr determination as creatinine is one of the parameters our nutrition score is based on.
Read the detailed description
30 patients will randomly be selected for SGA examination and comparison to the MARK results every month. Frequency and duration of hospitalizations within the 5-month collection period will documented, mortality will be documented as well. Effect of different nutritional supplementations or IDPN will be assessed. The MARK nutrition screening will be used for all patients at the beginning of every month. Monthly Biochemical data using a blood sample taken immediately before dialysis will be used to calculate a value between 0-100 showing patient's monthly nutritional status. Data for the SGA will be collected for the same dialysis patients randomly selected at the same month. The nutritional state of the patients according to the SGA will be assessed by two investigators. A statistical test will be held for agreement between observers (Cohen's k concordant coefficient).
A sub group of 30 patients will provide blood smample to assess a Near Infra Red (NIR) method for Cr determination. Application of chemometric approach will serve for constructing a fitting curve between tradtional CR measurment with NIR method.
- Conditions
- Malnutrition, Inflammation, Morbidity, Mortality
- Medical subject headings
- Malnutrition, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zvi Barnea, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042405
- Sponsor's protocol ID
- 0074-09-WOMC
- Acronym
- Hemodialysis
- Status last verified
- Jan 2020
- First submitted
- 1 Jan 2010
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Risk Computerized Predictive Method in HD Patients by Nutritional Scoring & Assesment of NIR Method for Cr Determination
- ClinicalTrials.gov ID
- NCT01042405
- Acronym / sponsor ID
- Hemodialysis / 0074-09-WOMC
- Conditions
- Malnutrition, Inflammation, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Feb 2010 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Jan 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.
The aim of the study is to develop a simple computer program, evaluating nutritional status of HD patients. The programming will enable to perform a nutritional screening, based on biochemical measures, taken as part of HD patients' routine care every month. The program will identify patients at risk of malnutrition, define the degree of malnutrition, and identify patients who at risk for increased morbidity and mortality. Patients who are at risk of malnutrition will be treated by a standard nutrition; dietary counseling (high protein diet, appropriate calories intake and use of oral supplementation. Intra-dialytic parenteral nutrition (IDPN) will be used for patients who fail to improve nutrition status by standard nutrition care, as a second line treatment. The effect of IDPN on their nutrition status will be evaluated. A sub group of 30 patients will provide blood smample to assess a NIR method for Cr determination as creatinine is one of the parameters our nutrition score is based on.
Detailed description
30 patients will randomly be selected for SGA examination and comparison to the MARK results every month. Frequency and duration of hospitalizations within the 5-month collection period will documented, mortality will be documented as well. Effect of different nutritional supplementations or IDPN will be assessed. The MARK nutrition screening will be used for all patients at the beginning of every month. Monthly Biochemical data using a blood sample taken immediately before dialysis will be used to calculate a value between 0-100 showing patient's monthly nutritional status. Data for the SGA will be collected for the same dialysis patients randomly selected at the same month. The nutritional state of the patients according to the SGA will be assessed by two investigators. A statistical test will be held for agreement between observers (Cohen's k concordant coefficient).
A sub group of 30 patients will provide blood smample to assess a Near Infra Red (NIR) method for Cr determination. Application of chemometric approach will serve for constructing a fitting curve between tradtional CR measurment with NIR method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients on hemodialysis, Wolfson Hospital
Key inclusion criteria (1 listed)
- All dialysis patients in Wolfson Medical Center dialysis unit above the age of 18 years and on dialysis more than 3 months.
Key exclusion criteria (1 listed)
- Patients with bilateral plegia. Hemiplegic organs of a patient (not the entire patient).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
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 and Inflammation, run by Wolfson 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 1 inclusion and 1 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 Feb 2020. 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 Zvi Barnea, MD (97235028287, barnea@wmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 5 Feb 2020.