MalnutritionNCT02023177
Phase Angle and Mortality in Patients With Cirrhosis
An observational study of Malnutrition, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malnutrition
- How many people
- 249 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2008to Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be selected from the Liver Clinic at the Department of Gastroenterology in a tertiary care center in Mexico
Who may be able to join
- 18-65 years old ambulatory patients Diagnosis of liver cirrhosis
Who cannot join
- Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
About this study
Official title: Phase Angle as a Nutritional Marker Related to Prognosis Inpatients With Cirrhosis: A Cutt-off Value for Mexican Population
A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.
Read the detailed description
Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. Despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.
- Conditions
- Malnutrition
- Keywords
- phase angle, liver cirrhosis, mortality, malnutrition
- Medical subject headings
- Malnutrition, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase angle | Phase angle obtained from bioelectrical impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Phase angle obtained from bioelectrical impedance
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2008
- Primary completionJul 2013
- Study completionSep 2013
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre, MD MSci, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranAstrid Ruiz-Margáin, B.Sci, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023177
- Sponsor's protocol ID
- PhA01
- Status last verified
- Nov 2014
- First submitted
- 18 Dec 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Angle as a Nutritional Marker Related to Prognosis Inpatients With Cirrhosis: A Cutt-off Value for Mexican Population
- ClinicalTrials.gov ID
- NCT02023177
- Acronym / sponsor ID
- PhA01
- Conditions
- Malnutrition
- Keywords
- phase angle, liver cirrhosis, mortality, malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Dec 2013 (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.
A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.
Detailed description
Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. Despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase angle | – | –Phase angle obtained from bioelectrical impedance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be selected from the Liver Clinic at the Department of Gastroenterology in a tertiary care center in Mexico
Key inclusion criteria (1 listed)
- 18-65 years old ambulatory patients Diagnosis of liver cirrhosis
Key exclusion criteria (1 listed)
- Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections
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
Nutritional status
Time frame: Baseline
Phase angle obtained from bioelectrical impedance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Aldo Torre, MD MSci study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Astrid Ruiz-Margáin, B.Sci principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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: finished, as of the sponsor's last update on 18 Nov 2014. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutritional status (time frame: Baseline). It is what the study was designed to measure, not a finding.
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 18 Nov 2014.