Liver CirrhosisNCT02926261
Methods for Nutritional Assessment in Cirrhosis
An observational study of Liver Cirrhosis and Cachexia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Cachexia, Malnutrition
- What is being tested?
- Bioelectrical impedance vector analysis
- How many people
- 180 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2016to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of patients with cirrhosis
Who may be able to join
- Diagnosis of cirrhosis
- No restriction of etiology
- 18-75 years
- Child-Pugh stage A/B/C
- Signed informed consent
Who cannot join
- Pregnancy
- Extremity amputation
- Malignancy different from hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico City, 14080
Aldo Torre Delgadillo, BSc, MSc, detoal@yahoo.mx
About this study
Official title: Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.
Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.
- Conditions
- Liver Cirrhosis, Cachexia, Malnutrition
- Being tested
- Bioelectrical impedance vector analysis
- Medical subject headings
- Liver Cirrhosis, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical impedance vector analysisOther
Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Characterization of nutritional status by three methods of nutritional assessment
- Bioelectrical impedance vector analysis
- CT scan
- Handgrip strength
Measured: Evaluation at time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Cross-sectional
- Enrolment
- 180 participants (estimated)
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, MSc, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926261
- Sponsor's protocol ID
- BIVA0978
- Status last verified
- Jan 2020
- First submitted
- 5 Oct 2016
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT02926261
- Acronym / sponsor ID
- BIVA0978
- Conditions
- Liver Cirrhosis, Cachexia, Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Oct 2016 (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.
Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.
Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients with cirrhosis
Key inclusion criteria (5 listed)
- Diagnosis of cirrhosis
- No restriction of etiology
- 18-75 years
- Child-Pugh stage A/B/C
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Extremity amputation
- Malignancy different from hepatocellular carcinoma
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 |
|---|---|---|
| Bioelectrical impedance vector analysisEvaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan | Other | – |
Primary outcome
Nutritional status
Time frame: Evaluation at time of recruitment
Characterization of nutritional status by three methods of nutritional assessment * Bioelectrical impedance vector analysis * CT scan * Handgrip strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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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, MSc 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 Liver Cirrhosis and Cachexia, 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 5 inclusion and 3 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 28 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Torre, MD, MSc (5554870900 ext. 2711, detoal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: Evaluation at time of recruitment). 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 28 Feb 2020.