Methods for Nutritional Assessment in Cirrhosis | NCT02926261

Studies
Methods for Nutritional Assessment in Cirrhosis

NCT02926261

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Unknown status

Last Update Posted

Feb 28, 2020Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Liver Cirrhosis
Cachexia
Malnutrition

Interventions

Bioelectrical impedance vector analysis

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 2020

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

Dec 2016Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Oct 5, 2016

First Submission Date that Met QC Criteria

Oct 5, 2016

First Posted Date

Oct 6, 2016Estimated

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

Feb 27, 2020

Last Update Posted Date

Feb 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ALDO TORRE DELGADILLO, MD, MSc, 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

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.

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

180Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bioelectrical impedance vector analysis	Other	Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nutritional status	Characterization of nutritional status by three methods of nutritional assessment Bioelectrical impedance vector analysis CT scan Handgrip strength	Evaluation at time of recruitment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of cirrhosis
No restriction of etiology
18-75 years
Child-Pugh stage A/B/C
Signed informed consent

Exclusion Criteria:

Pregnancy
Extremity amputation
Malignancy different from hepatocellular carcinoma

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 patients with cirrhosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aldo Torre, MD, MSc	Contact	5554870900	2711	detoal@yahoo.com

Overall Officials

Name	Affiliation	Role
Aldo Torre, MD, MSc	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Recruiting	Mexico City	Mexico City	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
D008103	Liver Cirrhosis
D002100	Cachexia
D044342	Malnutrition

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided