Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502719
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-08-04
Brief Title:
Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients With Liver Cirrhosis
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares two nutritional screening questionnaires in cirrhotic patients All patients will be assessed with both questionnaires besides a complete nutritional assessment
Detailed Description:
Disease-related malnutrition is a health problem with high prevalence and associated costs Poor nutritional status has an unfavorable effect on clinical outcomes in terms of complications post-transplant survival and mortality in relation to the liver in addition to a decrease in quality of life The same complications of liver disease such as hypoalbuminemia or ascites make it difficult to assess malnutrition in cirrhotic patients
The use of screening tools defines the first step in the prevention and treatment of patients at risk of malnutrition or overt malnutrition The use of screening tools to detect malnutrition upon admission to hospital improves the identification of malnourished patients by 50-80 early treatment of patients can reduce hospital stay It has been observed that nutritional interventions after assessment of nutritional risk appear to prevent complications and improve quality of life and survival rate in cirrhotic patients
Due to changes in body composition in cirrhotic patients ie ascites the most common questionnaires for screening for malnutrition eg MUST NRS-2002 which use anthropometric measures have not been validated in cirrhosis and are therefore not considered suitable for malnutrition screening On the contrary in recent years two specific nutritional screening tools have been developed for cirrhotic patients the Royal Free Hospital Nutritional Prioritizing Tool RFH-NPT and the Liver Disease Undernutrition Screening Tool LDUST Both questionnaires however require further validation against clinical outcomes in cirrhotic patients
This study will use two screening tools for malnutrition risk RFH-NPT and LDUST to compare their validity in detecting malnutrition risk in patients with liver cirrhosis These tools will be validated by performing a nutritional assessment with the new diagnostic criteria of malnutrition promoted by the Global Leadership Initiative on Malnutrition
Sarcopenia can occur in malnourished cirrhotic patients so it will be of interest to know what the possible prevalence may be in the sample of patients studied The use of the screening questionnaire SARC-F will allow an assessment of the prevalence of risk of sarcopenia Situations such as malnutrition or sarcopenia can have an impact on the patients health-related quality of life so this parameter will be assessed using the Chronic Liver Disease Questionnaire
The use of screening tools defines the first step in the prevention and treatment of patients at risk of malnutrition or overt malnutrition The use of screening tools to detect malnutrition upon admission to hospital improves the identification of malnourished patients by 50-80 early treatment of patients can reduce hospital stay It has been observed that nutritional interventions after assessment of nutritional risk appear to prevent complications and improve quality of life and survival rate in cirrhotic patients
Due to changes in body composition in cirrhotic patients ie ascites the most common questionnaires for screening for malnutrition eg MUST NRS-2002 which use anthropometric measures have not been validated in cirrhosis and are therefore not considered suitable for malnutrition screening On the contrary in recent years two specific nutritional screening tools have been developed for cirrhotic patients the Royal Free Hospital Nutritional Prioritizing Tool RFH-NPT and the Liver Disease Undernutrition Screening Tool LDUST Both questionnaires however require further validation against clinical outcomes in cirrhotic patients
This study will use two screening tools for malnutrition risk RFH-NPT and LDUST to compare their validity in detecting malnutrition risk in patients with liver cirrhosis These tools will be validated by performing a nutritional assessment with the new diagnostic criteria of malnutrition promoted by the Global Leadership Initiative on Malnutrition
Sarcopenia can occur in malnourished cirrhotic patients so it will be of interest to know what the possible prevalence may be in the sample of patients studied The use of the screening questionnaire SARC-F will allow an assessment of the prevalence of risk of sarcopenia Situations such as malnutrition or sarcopenia can have an impact on the patients health-related quality of life so this parameter will be assessed using the Chronic Liver Disease Questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None