Prognostic Value of Different Nutritional Screening Tools in Acute Pancreatitis (NuRiPa)

December 23, 2024 updated by: University Medicine Greifswald

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • verified diagnosis of acute pancreatitis
  • provision of informed consent

Exclusion Criteria:

  • pregnancy
  • inability to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relation of Nutritional Risk Index to length of hospital stay
Time Frame: Baseline
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
Relation of Mini Nutritional Assessment - Short Form to length of hospital stay
Time Frame: Baseline
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
Relation of Subjective Global Assessment to length of hospital stay
Time Frame: Baseline
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
Relation of Malnutrition Universal Screening Tool to length of hospital stay
Time Frame: Baseline
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
Relation of Short Nutritional Assessment Questionaire to length of hospital stay
Time Frame: Baseline
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
Relation of fat-free mass to length of hospital stay
Time Frame: Baseline
Association between fat-free mass determined by bioelectrical impedance analysis and length of hospital stay.
Baseline
Relation of fat mass to length of hospital stay
Time Frame: Baseline
Association between fat mass determined by bioelectrical impedance analysis and length of hospital stay.
Baseline
Relation of skeletal muscle mass to length of hospital stay
Time Frame: Baseline
Association between skeletal muscle mass determined by computed tomography and length of hospital stay.
Baseline
Relation of waist circumference to length of hospital stay
Time Frame: Baseline
Association between waist circumference and length of hospital stay.
Baseline
Relation of albumin to length of hospital stay
Time Frame: Baseline
Association between plasma albumin concentration at admission and length of hospital stay.
Baseline
Relation of C-reactive protein to length of hospital stay
Time Frame: Baseline
Association between plasma C-reactive protein concentration at admission and length of hospital stay.
Baseline
Relation of Nutritional Risk Screening 2002 to disease severity
Time Frame: Baseline
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
Relation of Nutritional Risk Index to disease severity
Time Frame: Baseline
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
Relation of Mini Nutritional Assessment - Short Form to disease severity
Time Frame: Baseline
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
Relation of Subjective Global Assessment to disease severity
Time Frame: Baseline
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
Relation of Malnutrition Universal Screening Tool to disease severity
Time Frame: Baseline
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
Relation of Short Nutritional Assessment Questionaire to disease severity
Time Frame: Baseline
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
Relation of fat-free mass to disease severity
Time Frame: Baseline
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
Relation of fat mass to disease severity
Time Frame: Baseline
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
Relation of skeletal muscle mass to disease severity
Time Frame: Baseline
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
Relation of waist circumference to disease severity
Time Frame: Baseline
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
Relation of albumin to disease severity
Time Frame: Baseline
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
Relation of C-reactive protein to disease severity
Time Frame: Baseline
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
Relation of Nutritional Risk Screening 2002 to mortality
Time Frame: Baseline
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
Relation of Nutritional Risk Index to mortality
Time Frame: Baseline
Association between Nutritional Risk Index (Index) result and in-hospital mortality. NRI is a continuous measure, with lower values indicating greater nutritional risk.
Baseline
Relation of Mini Nutritional Assessment - Short Form to mortality
Time Frame: Baseline
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
Relation of Subjective Global Assessment to mortality
Time Frame: Baseline
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
Relation of Malnutrition Universal Screening Tool to mortality
Time Frame: Baseline
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
Relation of Short Nutritional Assessment Questionaire to mortality
Time Frame: Baseline
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
Relation of fat-free mass to mortality
Time Frame: Baseline
Association between fat-free mass determined by bioelectrical impedance analysis and in-hospital mortality.
Baseline
Relation of fat mass to mortality
Time Frame: Baseline
Association between fat mass determined by bioelectrical impedance analysis and in-hospital mortality.
Baseline
Relation of skeletal muscle mass to mortality
Time Frame: Baseline
Association between skeletal muscle mass determined by computed tomography and in-hospital mortality.
Baseline
Relation of waist circumference to mortality
Time Frame: Baseline
Association between waist circumference and in-hospital mortality.
Baseline
Relation of albumin to mortality
Time Frame: Baseline
Association between plasma albumin concentration at admission and in-hospital mortality.
Baseline
Relation of C-reactive protein to mortality
Time Frame: Baseline
Association between plasma C-reactive protein concentration at admission and in-hospital mortality.
Baseline
Relation of Nutritional Risk Screening 2002 to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of Nutritional Risk Index to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of Mini Nutritional Assessment - Short Form to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of Subjective Global Assessment to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of Malnutrition Universal Screening Tool to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of Short Nutritional Assessment Questionaire to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of fat-free mass to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of fat mass to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of skeletal muscle mass to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of waist circumference to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of albumin to rehospitalization
Time Frame: 6 months after initial hospital admission
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
Relation of C-reactive protein to rehospitalization
Time Frame: 6 months after initial hospital admission
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali A Aghdassi, Professor, University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BB 112/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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