Clinical trial NCT05613673: Prognostic Value of Different Nutritional Screening Tools in Acute Pancreatitis
Official title: Comparison of the Prognostic Value of Different Nutritional Assessment Scores Regarding the Course in Acute Pancreatitis - a Prospective Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Pancreatitis
Malnutrition
Keywords: Acute pancreatitis
Nutritional screening
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* verified diagnosis of acute pancreatitis
* provision of informed consent

Exclusion Criteria:

* pregnancy
* inability to provide consent

Primary outcomes:
measure: Relation of Nutritional Risk Screening 2002 to length of hospital stay
timeFrame: Baseline
Secondary outcomes:
measure: Relation of Nutritional Risk Index to length of hospital stay
timeFrame: Baseline
measure: Relation of Mini Nutritional Assessment - Short Form to length of hospital stay
timeFrame: Baseline
measure: Relation of Subjective Global Assessment to length of hospital stay
timeFrame: Baseline
measure: Relation of Malnutrition Universal Screening Tool to length of hospital stay
timeFrame: Baseline
measure: Relation of Short Nutritional Assessment Questionaire to length of hospital stay
timeFrame: Baseline
measure: Relation of fat-free mass to length of hospital stay
timeFrame: Baseline
measure: Relation of fat mass to length of hospital stay
timeFrame: Baseline
measure: Relation of skeletal muscle mass to length of hospital stay
timeFrame: Baseline
measure: Relation of waist circumference to length of hospital stay
timeFrame: Baseline
measure: Relation of albumin to length of hospital stay
timeFrame: Baseline
measure: Relation of C-reactive protein to length of hospital stay
timeFrame: Baseline
measure: Relation of Nutritional Risk Screening 2002 to disease severity
timeFrame: Baseline
measure: Relation of Nutritional Risk Index to disease severity
timeFrame: Baseline
measure: Relation of Mini Nutritional Assessment - Short Form to disease severity
timeFrame: Baseline
measure: Relation of Subjective Global Assessment to disease severity
timeFrame: Baseline
measure: Relation of Malnutrition Universal Screening Tool to disease severity
timeFrame: Baseline
measure: Relation of Short Nutritional Assessment Questionaire to disease severity
timeFrame: Baseline
measure: Relation of fat-free mass to disease severity
timeFrame: Baseline
measure: Relation of fat mass to disease severity
timeFrame: Baseline
measure: Relation of skeletal muscle mass to disease severity
timeFrame: Baseline
measure: Relation of waist circumference to disease severity
timeFrame: Baseline
measure: Relation of albumin to disease severity
timeFrame: Baseline
measure: Relation of C-reactive protein to disease severity
timeFrame: Baseline
measure: Relation of Nutritional Risk Screening 2002 to mortality
timeFrame: Baseline
measure: Relation of Nutritional Risk Index to mortality
timeFrame: Baseline
measure: Relation of Mini Nutritional Assessment - Short Form to mortality
timeFrame: Baseline
measure: Relation of Subjective Global Assessment to mortality
timeFrame: Baseline
measure: Relation of Malnutrition Universal Screening Tool to mortality
timeFrame: Baseline
measure: Relation of Short Nutritional Assessment Questionaire to mortality
timeFrame: Baseline
measure: Relation of fat-free mass to mortality
timeFrame: Baseline
measure: Relation of fat mass to mortality
timeFrame: Baseline
measure: Relation of skeletal muscle mass to mortality
timeFrame: Baseline
measure: Relation of waist circumference to mortality
timeFrame: Baseline
measure: Relation of albumin to mortality
timeFrame: Baseline
measure: Relation of C-reactive protein to mortality
timeFrame: Baseline
measure: Relation of Nutritional Risk Screening 2002 to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of Nutritional Risk Index to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of Mini Nutritional Assessment - Short Form to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of Subjective Global Assessment to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of Malnutrition Universal Screening Tool to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of Short Nutritional Assessment Questionaire to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of fat-free mass to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of fat mass to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of skeletal muscle mass to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of waist circumference to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of albumin to rehospitalization
timeFrame: 6 months after initial hospital admission
measure: Relation of C-reactive protein to rehospitalization
timeFrame: 6 months after initial hospital admission
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Ali A Aghdassi, Professor
role: PRINCIPAL_INVESTIGATOR
References: