InflammationNCT00410137
Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients
An observational study of Inflammation and Body Composition, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Body Composition
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Apr 2008
- 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
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 neuro-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 neuro-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 10Show fewer
- Acute vasculitis
- Severe systemic infections
- Heart failure (NYHA class III-IV)
- The receipt of any investigational drug within 1 month prior to initiating of this study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Tsrifin, 70300
Ilia Beberashvili, MD, +972577346133, iliab@asaf.health.gov.il
Ilia Beberashvili, MD
About this study
prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.
- Conditions
- Inflammation, Body Composition
- Medical subject headings
- Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startMar 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Ilia Beberashvili, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410137
- Sponsor's protocol ID
- 43/06
- Status last verified
- Dec 2006
- First submitted
- 10 Dec 2006
- Last updated
- 12 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00410137
- Acronym / sponsor ID
- 43/06
- Conditions
- Inflammation, Body Composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2006
- Study completion
- Apr 2008
- First posted
- 12 Dec 2006 (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.
prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 neuro-muscular diseases
- Informed consent obtained before any trial-related activities
Key exclusion criteria (10 listed)
- Patients with edema, pleural effusion or ascites at their initial assessment
- Patients with active malignant disease or liver cirrhosis
- Patients with neuro-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.
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 12 Dec 2006.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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
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 Inflammation and Body Composition, 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 10 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 12 Dec 2006. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 12 Dec 2006.