Acute PancreatitisNuRiPaNCT05613673
Prognostic Value of Different Nutritional Screening Tools in Acute Pancreatitis
An observational study of Acute Pancreatitis and Malnutrition, run by University Medicine Greifswald at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Malnutrition
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 11 Oct 2022to 5 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients admitted to the hospital for treatment of acute pancreatitis will be identified in the respective wards and will be approached for study inclusion upon confirmation of diagnosis.
Who may be able to join
- verified diagnosis of acute pancreatitis
- provision of informed consent
Who cannot join
- pregnancy
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the detailed 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.
- Conditions
- Acute Pancreatitis, Malnutrition
- Being tested
- No intervention - observational study only
- Keywords
- Acute pancreatitis, Nutritional screening
- Medical subject headings
- Pancreatitis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational study onlyOther
No intervention - observational study only
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (47)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Relation of fat mass to length of hospital stay
Association between fat mass determined by bioelectrical impedance analysis and length of hospital stay.
Measured: Baseline
Relation of skeletal muscle mass to length of hospital stay
Association between skeletal muscle mass determined by computed tomography and length of hospital stay.
Measured: Baseline
Relation of waist circumference to length of hospital stay
Association between waist circumference and length of hospital stay.
Measured: Baseline
Relation of albumin to length of hospital stay
Association between plasma albumin concentration at admission and length of hospital stay.
Measured: Baseline
Relation of C-reactive protein to length of hospital stay
Association between plasma C-reactive protein concentration at admission and length of hospital stay.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Relation of fat-free mass to mortality
Association between fat-free mass determined by bioelectrical impedance analysis and in-hospital mortality.
Measured: Baseline
Relation of fat mass to mortality
Association between fat mass determined by bioelectrical impedance analysis and in-hospital mortality.
Measured: Baseline
Relation of skeletal muscle mass to mortality
Association between skeletal muscle mass determined by computed tomography and in-hospital mortality.
Measured: Baseline
Relation of waist circumference to mortality
Association between waist circumference and in-hospital mortality.
Measured: Baseline
Relation of albumin to mortality
Association between plasma albumin concentration at admission and in-hospital mortality.
Measured: Baseline
Relation of C-reactive protein to mortality
Association between plasma C-reactive protein concentration at admission and in-hospital mortality.
Measured: Baseline
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
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.
Measured: 6 months after initial hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Oct 2022
- Primary completion5 Oct 2024
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali A Aghdassi, Professor, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613673
- Sponsor's protocol ID
- BB 112/22
- Acronym
- NuRiPa
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prognostic Value of Different Nutritional Assessment Scores Regarding the Course in Acute Pancreatitis - a Prospective Trial
- ClinicalTrials.gov ID
- NCT05613673
- Acronym / sponsor ID
- NuRiPa / BB 112/22
- Conditions
- Acute Pancreatitis, Malnutrition
- Keywords
- Acute pancreatitis, Nutritional screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients admitted to the hospital for treatment of acute pancreatitis will be identified in the respective wards and will be approached for study inclusion upon confirmation of diagnosis.
Key inclusion criteria (2 listed)
- verified diagnosis of acute pancreatitis
- provision of informed consent
Key exclusion criteria (2 listed)
- pregnancy
- inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational study onlyNo intervention - observational study only | Other | – |
Primary outcome
Relation of Nutritional Risk Screening 2002 to length of hospital stay
Time frame: Baseline
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.
47 secondary outcomes
Relation of Nutritional Risk Index to length of hospital stay
Time frame: Baseline
Relation of Mini Nutritional Assessment - Short Form to length of hospital stay
Time frame: Baseline
Relation of Subjective Global Assessment to length of hospital stay
Time frame: Baseline
Relation of Malnutrition Universal Screening Tool to length of hospital stay
Time frame: Baseline
Relation of Short Nutritional Assessment Questionaire to length of hospital stay
Time frame: Baseline
Relation of fat-free mass to length of hospital stay
Time frame: Baseline
Relation of fat mass to length of hospital stay
Time frame: Baseline
Relation of skeletal muscle mass to length of hospital stay
Time frame: Baseline
Relation of waist circumference to length of hospital stay
Time frame: Baseline
Relation of albumin to length of hospital stay
Time frame: Baseline
Relation of C-reactive protein to length of hospital stay
Time frame: Baseline
Relation of Nutritional Risk Screening 2002 to disease severity
Time frame: Baseline
Relation of Nutritional Risk Index to disease severity
Time frame: Baseline
Relation of Mini Nutritional Assessment - Short Form to disease severity
Time frame: Baseline
Relation of Subjective Global Assessment to disease severity
Time frame: Baseline
Relation of Malnutrition Universal Screening Tool to disease severity
Time frame: Baseline
Relation of Short Nutritional Assessment Questionaire to disease severity
Time frame: Baseline
Relation of fat-free mass to disease severity
Time frame: Baseline
Relation of fat mass to disease severity
Time frame: Baseline
Relation of skeletal muscle mass to disease severity
Time frame: Baseline
Relation of waist circumference to disease severity
Time frame: Baseline
Relation of albumin to disease severity
Time frame: Baseline
Relation of C-reactive protein to disease severity
Time frame: Baseline
Relation of Nutritional Risk Screening 2002 to mortality
Time frame: Baseline
Relation of Nutritional Risk Index to mortality
Time frame: Baseline
Relation of Mini Nutritional Assessment - Short Form to mortality
Time frame: Baseline
Relation of Subjective Global Assessment to mortality
Time frame: Baseline
Relation of Malnutrition Universal Screening Tool to mortality
Time frame: Baseline
Relation of Short Nutritional Assessment Questionaire to mortality
Time frame: Baseline
Relation of fat-free mass to mortality
Time frame: Baseline
Relation of fat mass to mortality
Time frame: Baseline
Relation of skeletal muscle mass to mortality
Time frame: Baseline
Relation of waist circumference to mortality
Time frame: Baseline
Relation of albumin to mortality
Time frame: Baseline
Relation of C-reactive protein to mortality
Time frame: Baseline
Relation of Nutritional Risk Screening 2002 to rehospitalization
Time frame: 6 months after initial hospital admission
Relation of Nutritional Risk Index to rehospitalization
Time frame: 6 months after initial hospital admission
Relation of Mini Nutritional Assessment - Short Form to rehospitalization
Time frame: 6 months after initial hospital admission
Relation of Subjective Global Assessment to rehospitalization
Time frame: 6 months after initial hospital admission
Relation of Malnutrition Universal Screening Tool to rehospitalization
Time frame: 6 months after initial hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali A Aghdassi, Professor principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Malnutrition, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation of Nutritional Risk Screening 2002 to length of hospital stay (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.