Methods for Nutritional Assessment in Cirrhosis

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02926261
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Cachexia; Malnutrition	Other: Bioelectrical impedance vector analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Nutritional status [Evaluation at time of recruitment]

   Characterization of nutritional status by three methods of nutritional assessment Bioelectrical impedance vector analysis CT scan Handgrip strength

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico City	DF	Mexico	14080

Sponsors and Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

• Principal Investigator: Aldo Torre, MD, MSc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ALDO TORRE DELGADILLO, MD, MSc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• ClinicalTrials.gov Identifier: NCT02926261
• Other Study ID Numbers: BIVA0978
• First Posted: Oct 6, 2016
• Last Update Posted: Feb 28, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Liver Cirrhosis; Malnutrition; Fibrosis; Cachexia

Study Results

No Results Posted as of Feb 28, 2020