NCT02023177

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

5.5 years

First QC Date

December 18, 2013

Last Update Submit

November 14, 2014

Conditions

Malnutrition

Keywords

phase angleliver cirrhosismortalitymalnutrition

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Phase angle obtained from bioelectrical impedance

    Baseline

Other Outcomes (3)

  • Nutritional status

    9 months

  • Nutritional status

    18 months

  • Nutritional status

    24 months

Study Arms (1)

Phase angle

Phase angle obtained from bioelectrical impedance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will be selected from the Liver Clinic at the Department of Gastroenterology in a tertiary care center in Mexico

You may qualify if:

  • years old ambulatory patients Diagnosis of liver cirrhosis

You may not qualify if:

  • Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

MalnutritionLiver Cirrhosis

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aldo Torre, MD MSci

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY DIRECTOR

  • Astrid Ruiz-Margáin, B.Sci

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 30, 2013

Study Start

January 1, 2008

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

ME(1)