InfectionNCT02017301
Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients
An observational study of Infection, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary widely, with several periods of fasting, and sometimes insufficient nutritional support. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infection
- What is being tested?
- Nutritional assessment
- How many people
- 79 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2012to Apr 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 hospitalized cirrhotic patients
Who may be able to join
- Age 18-75 years old
- Patients with confirmed cirrhosis.
- Any etiology
- Hospitalized with acute decompensation of cirrhosis
- Signed informed consent
Who cannot join
- Pregnancy
- Amputation
- Incomplete data
Trial locations and contacts
1 site in 1 country.
Astrid Ruiz-Margáin, M.Sc contact
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
México, D.F, 14080
Aldo
Aldo Torre Delgadillo, M.D. M.S.ci
About this study
Official title: Influence of Acute Decompensation on Body Composition Determined by Bioelectrical Impedance Vector Analysis
Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary widely, with several periods of fasting, and sometimes insufficient nutritional support. Therefore patients are prone to develop malnutrition or, the already present malnutrition worsens its status.
Our aim is to evaluate the daily changes in nutritional status in patients with acute decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.
- Conditions
- Infection
- Being tested
- Nutritional assessment
- Keywords
- Liver Cirrhosis,Infection, Impedance, Body Composition
- Medical subject headings
- Infections, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional assessmentOther
Daily nutritional assessment with bioelectrical impedance vector analysis, phase angle and mid-arm muscle circumference
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nutritional status
Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle)
Measured: Daily measurement up to 30 days
Secondary outcomes (1)
Evaluation of inflammatory cytokines
ELISA's test
Measured: Samples will be collected at the baseline evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- 79 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 Delgadillo, M.D. M.Sc, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranAstrid Ruiz-Margáin, M.Sc, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017301
- Sponsor's protocol ID
- GAS-800-12-13-1
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2012
- Last updated
- 1 Feb 2019
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Acute Decompensation on Body Composition Determined by Bioelectrical Impedance Vector Analysis
- ClinicalTrials.gov ID
- NCT02017301
- Acronym / sponsor ID
- GAS-800-12-13-1
- Conditions
- Infection
- Keywords
- Liver Cirrhosis,Infection, Impedance, Body Composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 20 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.
Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary widely, with several periods of fasting, and sometimes insufficient nutritional support. Therefore patients are prone to develop malnutrition or, the already present malnutrition worsens its status.
Our aim is to evaluate the daily changes in nutritional status in patients with acute decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of hospitalized cirrhotic patients
Key inclusion criteria (5 listed)
- Age 18-75 years old
- Patients with confirmed cirrhosis.
- Any etiology
- Hospitalized with acute decompensation of cirrhosis
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Amputation
- Incomplete data
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 |
|---|---|---|
| Nutritional assessmentDaily nutritional assessment with bioelectrical impedance vector analysis, phase angle and mid-arm muscle circumference | Other | – |
Primary outcome
Changes in nutritional status
Time frame: Daily measurement up to 30 days
Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle)
1 secondary outcome
Evaluation of inflammatory cytokines
Time frame: Samples will be collected at the baseline evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- 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.
Astrid Ruiz-Margáin, M.Sc contact
Aldo Torre Delgadillo, M.D. M.Sc principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Astrid Ruiz-Margáin, M.Sc 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 Infection, 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 1 Feb 2019. 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 Delgadillo, M.D. M.Sc (54870900 ext. 2709, detoal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nutritional status (time frame: Daily measurement up to 30 days). 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 1 Feb 2019.