NCT05613673

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

November 4, 2022

Last Update Submit

December 23, 2024

Conditions

Keywords

Acute pancreatitisNutritional screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (47)

  • Relation of Nutritional Risk Index to length of hospital stay

    Baseline

  • Relation of Mini Nutritional Assessment - Short Form to length of hospital stay

    Baseline

  • Relation of Subjective Global Assessment to length of hospital stay

    Baseline

  • Relation of Malnutrition Universal Screening Tool to length of hospital stay

    Baseline

  • Relation of Short Nutritional Assessment Questionaire to length of hospital stay

    Baseline

  • +42 more secondary outcomes

Interventions

No intervention - observational study only

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • verified diagnosis of acute pancreatitis
  • provision of informed consent

You may not qualify if:

  • pregnancy
  • inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

PancreatitisMalnutrition

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Ali A Aghdassi, Professor

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 14, 2022

Study Start

October 11, 2022

Primary Completion

October 5, 2024

Study Completion

April 5, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations