HemodialysisPhase 4NCT00314834
Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
A Phase 4 study testing Intradialytic parenteral nutrition in people with Hemodialysis and Malnutrition, run by EZUS-LYON 1.
Trial summary
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Hemodialysis, Malnutrition
- What is being tested?
- Intradialytic parenteral nutrition
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2004
- Phase
- Phase 4
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 82 years
- hemodialysis vintage more than 6 months
- two of the following markers of malnutrition:
- body mass index (BMI) <= 20 kg/m2
- body weight loss within 6 months >= 10 percent
- serum albumin <= 35 g/L
- prealbumin <= 300 mg/L
Who cannot join
- weekly dialysis time < 12 h
- urea Kt/V index < 1.2
- serum albumin > 38 g/L
- prealbumin > 330 mg/L
- hypertriglyceridemia > 2.5 mmol/L
- associated comorbidities compromising the one-year survival
- treatment by oral, enteral or parenteral feeding during the last 3 months
- hospitalization at time of randomization
About this study
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score
Read the detailed description
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.
Patient eligibility: adult patients ≤ 82 y with HD vintage > 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.
Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.
Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.
- Conditions
- Hemodialysis, Malnutrition
- Being tested
- Intradialytic parenteral nutrition
- Keywords
- hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic parenteral nutritionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Secondary outcomes (1)
hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startJan 2001
- Study completionDec 2004
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 HemodialysisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants
Sponsor and investigators
- Lead sponsor
- EZUS-LYON 1
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Societe Francaise de Dialyse, Societe Francophone de Nutrition Enterale et Parenterale
- Investigators
- Noel JM Cano, MD-PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314834
- Sponsor's protocol ID
- EZUS-A1244
- Status last verified
- Mar 2005
- First submitted
- 14 Apr 2006
- Last updated
- 17 Apr 2006
- Results posted
- No
Publications
Cano NJ, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Chauveau P, Combe C, Laville M, Leverve XM; French Study Group for Nutrition in Dialysis. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91. doi: 10.1681/ASN.2007020184. Epub 2007 Jul 26.
PubMed 17656473
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00314834
- Acronym / sponsor ID
- EZUS-A1244
- Conditions
- Hemodialysis, Malnutrition
- Keywords
- hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 204 participants
- Lead sponsor
- EZUS-LYON 1University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Societe Francaise de Dialyse, Societe Francophone de Nutrition Enterale et Parenterale
- Study start
- Jan 2001
- Study completion
- Dec 2004
- First posted
- 17 Apr 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.
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score
Detailed description
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.
Patient eligibility: adult patients ≤ 82 y with HD vintage > 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.
Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.
Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 18 and 82 years
- hemodialysis vintage more than 6 months
- two of the following markers of malnutrition:
- body mass index (BMI) <= 20 kg/m2
- body weight loss within 6 months >= 10 percent
Key exclusion criteria (8 listed)
- weekly dialysis time < 12 h
- urea Kt/V index < 1.2
- serum albumin > 38 g/L
- prealbumin > 330 mg/L
- hypertriglyceridemia > 2.5 mmol/L
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 |
|---|---|---|
| Intradialytic parenteral nutrition | Drug | – |
Primary outcome
mortality
1 secondary outcome
hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2006.
- Derived from this study: PubMed 17656473Cano NJ, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Chauveau P, Combe C, Laville M, Leverve XM; French Study Group for Nutrition in Dialysis. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91. doi: 10.1681/ASN.2007020184. Epub 2007 Jul 26.
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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.
Noel JM Cano, MD-PhD study director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intradialytic parenteral nutrition in people with Hemodialysis and Malnutrition, run by EZUS-LYON 1.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Apr 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
mortality. 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 NCT00314834, 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 17 Apr 2006.