Vector Analysis of Body Composition in Hospitalized Cirrh... | NCT02017301

Studies
Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients

NCT02017301

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Unknown status

Last Update Posted

Feb 1, 2019Actual

Enrollment

79Estimated

Phase

Not provided

Conditions

Infection

Interventions

Nutritional assessment

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2021Estimated

First Submitted Date

Dec 6, 2012

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Feb 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ALDO TORRE DELGADILLO, Investigador Oficial, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPrincipal Investigator

Lead Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

79Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional assessment	Other	Daily nutritional assessment with bioelectrical impedance vector analysis, phase angle and mid-arm muscle circumference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in nutritional status	Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle)	Daily measurement up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of inflammatory cytokines	ELISA's test	Samples will be collected at the baseline evaluation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75 years old
Patients with confirmed cirrhosis.
Any etiology
Hospitalized with acute decompensation of cirrhosis
Signed informed consent

Exclusion Criteria:

Pregnancy
Amputation
Incomplete data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Cohort of hospitalized cirrhotic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aldo Torre Delgadillo, M.D. M.Sc	Contact	54870900	2709	detoal@yahoo.com
Astrid Ruiz-Margáin, M.Sc	Contact

Overall Officials

Name	Affiliation	Role
Aldo Torre Delgadillo, M.D. M.Sc	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Principal Investigator
Astrid Ruiz-Margáin, M.Sc	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran	Recruiting	México	D.F	14080	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided