Malnutrition Clinical Trial
— NuRiPaOfficial title:
Comparison of the Prognostic Value of Different Nutritional Assessment Scores Regarding the Course in Acute Pancreatitis - a Prospective Trial
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | September 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
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 |
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