Newly Registered Patients for Primary Liver TransplantationPROUDNCT00495859
Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
A study testing Immunonutrition and food for special medical purposes (FSMP) in people with Newly Registered Patients for Primary Liver Transplantation, run by Heidelberg University at 1 site in Germany.
Trial summary
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Newly Registered Patients for Primary Liver Transplantation
- What is being tested?
- Immunonutrition and food for special medical purposes (FSMP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 68 years of age
- Scheduled for first liver transplantation
- Written informed consent
- Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard
Who cannot join
- Patients < 18 and > 68 years
- Pregnant or nursing women
- History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
- Inability to take oral nutrition
- Patients with fulminant or subacute hepatic failure requiring urgent transplantation
- Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Surgery, Ruprecht-Karls University
Heidelberg, Baden-Wurttemberg, 69120
Peter Schemmer, MD, +4962215636500, peter.schemmer@med.uni-heidelberg.de
Arash Nickkholgh, MD, +4962215638584, arash.nickkholgh@med.uni-heidelberg.de
About this study
Official title: Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. This randomized placebo-controlled double blind multicenter clinical trial with longterm preoperative supplementation with such an enriched formula will evaluate evaluate effects of such formulas on patients' quality of life, survival, and posttransplant morbidities.
Read the detailed description
Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.
Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.
Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.
- Being tested
- Immunonutrition, food for special medical purposes (FSMP)
- Keywords
- Immunonutrition, immune enhancing diets, arginine, ω-3 fatty acids, nucleotides, liver transplantation, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
Also called ORAL IMPACT®
food for special medical purpose (FSMP)
food for special medical purposes (FSMP)Dietary supplement
Also called IMPACT-Control Supplement
an isocaloric isonitrogenous non-specific nutritional support
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily Receives: Dietary Supplement: Immunonutrition |
| 2 | Active comparator | controls receive an isocaloric isonitrogenous non-specific nutritional support Receives: Dietary Supplement: food for special medical purposes (FSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
Measured: while in the waiting list for liver transplantation
Secondary outcomes (1)
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
Measured: the first 12 posttransplant weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (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 Newly Registered Patients for Primary Liver TransplantationStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Peter Schemmer, MD, Principal investigator, Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495859
- Sponsor's protocol ID
- PROUD
- Acronym
- PROUD
- Status last verified
- Apr 2008
- First submitted
- 2 Jul 2007
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nickkholgh A, Schneider H, Encke J, Buchler MW, Schmidt J, Schemmer P. PROUD: effects of preoperative long-term immunonutrition in patients listed for liver transplantation. Trials. 2007 Aug 27;8:20. doi: 10.1186/1745-6215-8-20.
PubMed 17723147
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
- ClinicalTrials.gov ID
- NCT00495859
- Acronym / sponsor ID
- PROUD / PROUD
- Keywords
- Immunonutrition, immune enhancing diets, arginine, ω-3 fatty acids, nucleotides, liver transplantation, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 3 Jul 2007 (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.
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. This randomized placebo-controlled double blind multicenter clinical trial with longterm preoperative supplementation with such an enriched formula will evaluate evaluate effects of such formulas on patients' quality of life, survival, and posttransplant morbidities.
Detailed description
Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.
Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.
Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: ImmunonutritionStudy group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily |
| 2 | Active comparator | Dietary Supplement: food for special medical purposes (FSMP)controls receive an isocaloric isonitrogenous non-specific nutritional support |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 68 years of age
- Scheduled for first liver transplantation
- Written informed consent
- Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard
Key exclusion criteria (7 listed)
- Patients < 18 and > 68 years
- Pregnant or nursing women
- History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
- Inability to take oral nutrition
- Patients with fulminant or subacute hepatic failure requiring urgent transplantation
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 |
|---|---|---|
| ImmunonutritionAlso: ORAL IMPACT®food for special medical purpose (FSMP) | Dietary supplement | 1 |
| food for special medical purposes (FSMP)Also: IMPACT-Control Supplementan isocaloric isonitrogenous non-specific nutritional support | Dietary supplement | 2 |
Primary outcome
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
Time frame: while in the waiting list for liver transplantation
1 secondary outcome
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
Time frame: the first 12 posttransplant weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2008.
- Derived from this study: PubMed 17723147Nickkholgh A, Schneider H, Encke J, Buchler MW, Schmidt J, Schemmer P. PROUD: effects of preoperative long-term immunonutrition in patients listed for liver transplantation. Trials. 2007 Aug 27;8:20. doi: 10.1186/1745-6215-8-20.
- Heidelberg University HospitalLink provided by the sponsor.
- Learn more about the Department of Surgery at Ruprecht-Karls University of HeidelbergLink provided by the sponsor.
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.
Peter Schemmer, MD principal investigator
Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition and food for special medical purposes (FSMP) in people with Newly Registered Patients for Primary Liver Transplantation, run by Heidelberg University at 1 site in Germany.
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 7 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 4 Apr 2008. 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 Germany. 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 Peter Schemmer, MD (004962215636500, peter.schemmer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life. (time frame: while in the waiting list for liver transplantation). 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 NCT00495859, 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 4 Apr 2008.