Prognostic Value of Different Nutritional Screening Tools in Acute Pancreatitis

Malnutrition Clinical Trial

— NuRiPa  

Official title:

Comparison of the Prognostic Value of Different Nutritional Assessment Scores Regarding the Course in Acute Pancreatitis - a Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613673
• Other study ID #: BB 112/22
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University Medicine Greifswald
• Contact: Ali A Aghdassi, Professor
• Phone: +493834867230
• Email: ali.aghdassi[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to compare the prognostic value of different nutritional screening tools to predict the course of acute pancreatitis.

The main questions it aims to answer are:

• Which nutritional screening tool performs best to predict length of hospital stay?

• Which nutritional screening tool performs best to predict clinical outcome (disease severity, length of hospital stay, mortality, need for rehospitalization)?

Participants will answer questions regarding their nutritional status and undergo basic anthropometric assessments (e.g. measurement of waist circumference) to evaluate their risk of malnutrition.

Description:

Malnutrition seems to be related to an adverse outcome of acute pancreatitis. However, it is still unclear which of the various available nutritional screening tools is suited best to predict the clinical outcome in hospitalized patients with acute pancreatitis.

Therefore, in this study we compare the predictive performance of 6 different nutritional screening tools that are commonly applied in clinical practice regarding their respective associations with severity of acute pancreatitis, length of hospital stay, mortality and need for rehospitalization.

To determine patients' nutritional status, subjects will be inquired about their recent food intake as well as body weight and undergo basic anthropometric assessments according to the different screening tools.

Six months after the initial diagnosis patients will be contacted via mail to report on need for rehospitalization due to acute pancreatitis during this time period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• verified diagnosis of acute pancreatitis

• provision of informed consent

Exclusion Criteria:

• pregnancy

• inability to provide consent

Related Conditions & MeSH terms

• Acute Pancreatitis
• Malnutrition
• Pancreatitis

Intervention

Other:
• No intervention - observational study only
No intervention - observational study only

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation of Nutritional Risk Screening 2002 to length of hospital stay	Association between Nutritional Risk Screening 2002 (NRS-2002) result and length of hospital stay. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of Nutritional Risk Index to length of hospital stay	Association between Nutritional Risk Index (NRI) result and length of hospital stay. NRI is a continuous measure, with lower values indicating greater nutritional risk.	Baseline
Secondary	Relation of Mini Nutritional Assessment - Short Form to length of hospital stay	Association between Mini Nutritional Assessment - Short Form (MNA-SF) result and length of hospital stay. MNA-SF score ranges from 0 to 14, with lower values indicating greater nutritional risk.	Baseline
Secondary	Relation of Subjective Global Assessment to length of hospital stay	Association between Subjective Global Assessment result and length of hospital stay. SGA scores of A, B, and C indicate no malnutrition, moderate malnutrition or severe malnutrition, respectively.	Baseline
Secondary	Relation of Malnutrition Universal Screening Tool to length of hospital stay	Association between Malnutrition Universal Screening Tool (MUST) result and length of hospital stay. MUST score ranges from 0 to 6, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of Short Nutritional Assessment Questionaire to length of hospital stay	Association between Short Nutritional Assessment Questionaire (SNAQ) result and length of hospital stay. SNAQ score ranges from 0 to 7, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of fat-free mass to length of hospital stay	Association between fat-free mass determined by bioelectrical impedance analysis and length of hospital stay.	Baseline
Secondary	Relation of fat mass to length of hospital stay	Association between fat mass determined by bioelectrical impedance analysis and length of hospital stay.	Baseline
Secondary	Relation of skeletal muscle mass to length of hospital stay	Association between skeletal muscle mass determined by computed tomography and length of hospital stay.	Baseline
Secondary	Relation of waist circumference to length of hospital stay	Association between waist circumference and length of hospital stay.	Baseline
Secondary	Relation of albumin to length of hospital stay	Association between plasma albumin concentration at admission and length of hospital stay.	Baseline
Secondary	Relation of C-reactive protein to length of hospital stay	Association between plasma C-reactive protein concentration at admission and length of hospital stay.	Baseline
Secondary	Relation of Nutritional Risk Screening 2002 to disease severity	Association between Nutritional Risk Screening 2002 (NRS-2002) result and severity of acute pancreatitis based on the Revised Atlanta Classification. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Nutritional Risk Index to disease severity	Association between Nutritional Risk Index (NRI) result and severity of acute pancreatitis based on the Revised Atlanta Classification. NRI is a continuous measure, with lower values indicating greater nutritional risk. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Mini Nutritional Assessment - Short Form to disease severity	Association between Mini Nutritional Assessment - Short Form (MNA-SF) result and severity of acute pancreatitis based on the Revised Atlanta Classification. MNA-SF score ranges from 0 to 14, with lower values indicating greater nutritional risk. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Subjective Global Assessment to disease severity	Association between Subjective Global Assessment (SGA) result and severity of acute pancreatitis based on the Revised Atlanta Classification. SGA scores of A, B, and C indicate no malnutrition, moderate malnutrition or severe malnutrition, respectively. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Malnutrition Universal Screening Tool to disease severity	Association between Malnutrition Universal Screening Tool (MUST) result and severity of acute pancreatitis based on the Revised Atlanta Classification. MUST score ranges from 0 to 6, with higher values indicating greater nutritional risk. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Short Nutritional Assessment Questionaire to disease severity	Association between Short Nutritional Assessment Questionaire (SNAQ) result and severity of acute pancreatitis based on the Revised Atlanta Classification. SNAQ score ranges from 0 to 7, with higher values indicating greater nutritional risk. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of fat-free mass to disease severity	Association between fat-free mass determined by bioelectrical impedance analysis and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of fat mass to disease severity	Association between fat mass determined by bioelectrical impedance analysis and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of skeletal muscle mass to disease severity	Association between skeletal muscle mass determined by computed tomography and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of waist circumference to disease severity	Association between waist circumference and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of albumin to disease severity	Association between plasma albumin concentration at admission and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of C-reactive protein to disease severity	Association between plasma C-reactive protein concentration at admission and severity of acute pancreatitis based on the Revised Atlanta Classification. Based on the Revised Atlanta Classification acute pancreatitis can be graded as mild, moderate, or severe.	Baseline
Secondary	Relation of Nutritional Risk Screening 2002 to mortality	Association between Nutritional Risk Screening 2002 (NRS-2002) result and in-hospital mortality. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of Nutritional Risk Index to mortality	Association between Nutritional Risk Index (Index) result and in-hospital mortality. NRI is a continuous measure, with lower values indicating greater nutritional risk.	Baseline
Secondary	Relation of Mini Nutritional Assessment - Short Form to mortality	Association between Mini Nutritional Assessment - Short Form (MNA-SF) result and in-hospital mortality. MNA-SF score ranges from 0 to 14, with lower values indicating greater nutritional risk.	Baseline
Secondary	Relation of Subjective Global Assessment to mortality	Association between Subjective Global Assessment (SGA) result and in-hospital mortality. SGA scores of A, B, and C indicate no malnutrition, moderate malnutrition or severe malnutrition, respectively.	Baseline
Secondary	Relation of Malnutrition Universal Screening Tool to mortality	Association between Malnutrition Universal Screening Tool (MUST) result and in-hospital mortality. MUST score ranges from 0 to 6, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of Short Nutritional Assessment Questionaire to mortality	Association between Short Nutritional Assessment Questionaire (SNAQ) result and in-hospital mortality. SNAQ score ranges from 0 to 7, with higher values indicating greater nutritional risk.	Baseline
Secondary	Relation of fat-free mass to mortality	Association between fat-free mass determined by bioelectrical impedance analysis and in-hospital mortality.	Baseline
Secondary	Relation of fat mass to mortality	Association between fat mass determined by bioelectrical impedance analysis and in-hospital mortality.	Baseline
Secondary	Relation of skeletal muscle mass to mortality	Association between skeletal muscle mass determined by computed tomography and in-hospital mortality.	Baseline
Secondary	Relation of waist circumference to mortality	Association between waist circumference and in-hospital mortality.	Baseline
Secondary	Relation of albumin to mortality	Association between plasma albumin concentration at admission and in-hospital mortality.	Baseline
Secondary	Relation of C-reactive protein to mortality	Association between plasma C-reactive protein concentration at admission and in-hospital mortality.	Baseline
Secondary	Relation of Nutritional Risk Screening 2002 to rehospitalization	Association between Nutritional Risk Screening 2002 (NRS-2002) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.	6 months after initial hospital admission
Secondary	Relation of Nutritional Risk Index to rehospitalization	Association between Nutritional Risk Index (NRI) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. NRI is a continuous measure, with lower values indicating greater nutritional risk.	6 months after initial hospital admission
Secondary	Relation of Mini Nutritional Assessment - Short Form to rehospitalization	Association between Mini Nutritional Assessment - Short Form (MNA-SF) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. MNA-SF score ranges from 0 to 14, with lower values indicating greater nutritional risk.	6 months after initial hospital admission
Secondary	Relation of Subjective Global Assessment to rehospitalization	Association between Subjective Global Assessment (SGA) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. SGA scores of A, B, and C indicate no malnutrition, moderate malnutrition or severe malnutrition, respectively.	6 months after initial hospital admission
Secondary	Relation of Malnutrition Universal Screening Tool to rehospitalization	Association between Malnutrition Universal Screening Tool (MUST) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. MUST score ranges from 0 to 6, with higher values indicating greater nutritional risk.	6 months after initial hospital admission
Secondary	Relation of Short Nutritional Assessment Questionaire to rehospitalization	Association between Short Nutritional Assessment Questionaire (SNAQ) result and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital. SNAQ score ranges from 0 to 7, with higher values indicating greater nutritional risk.	6 months after initial hospital admission
Secondary	Relation of fat-free mass to rehospitalization	Association between fat-free mass determined by bioelectrical impedance analysis and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission
Secondary	Relation of fat mass to rehospitalization	Association between fat mass determined by bioelectrical impedance analysis and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission
Secondary	Relation of skeletal muscle mass to rehospitalization	Association between skeletal muscle mass determined by computed tomography and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission
Secondary	Relation of waist circumference to rehospitalization	Association between waist circumference and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission
Secondary	Relation of albumin to rehospitalization	Association between plasma albumin concentration at admission and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission
Secondary	Relation of C-reactive protein to rehospitalization	Association between plasma C-reactive protein concentration at admission and number of rehospitalizations due to acute pancreatitis within 6 months after initial admission to hospital.	6 months after initial hospital admission