Brief Summary

Malnutrition is a frequent problem in critically ill patients that is associated with detrimental clinical outcomes. To provide adequate nutritional support, current studies focused mostly on the choice of delivery timing, formula selection and the route of administration, little attention was paid to malnutrition related to exocrine pancreatic insufficiency (EPI). In fact, malnutrition is also a major consequence of pancreatic exocrine insufficiency and pancreatic damage is commonly observed in critically ill patients without prior pancreatic diseases. Hence, EPI associated malnutrition should be concerned due to the high prevalence of pancreatic damage in critically ill patients. The aims of this study is to evaluate the incidence of EPI in critically ill adult patients and explore its potential risk factors. Moreover, the efficacy of pancreatic enzyme supplementation therapy on malnutrition in ICU patients with specific clinical characteristics will be investigated.

Trial Health

On Track

Trial Health Score

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

Enrollment

362

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach

1 country

2 active sites

Status

completed

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

4 years study duration

Study Start

First participant enrolled

January 1, 2012

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed

Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

December 16, 2012

Last Update Submit

September 4, 2018

Conditions

Critical Illness Sepsis Diabetes Cardiac Arrest Acute Renal Failure Shock

Keywords

exocrine pancreatic insufficiencyfecal elastase-1amylaselipasecritical illnessenteral nutritionmalnutritionsepsisdiabeteshyperlactacidemiahemodialysismechanical ventilation

Outcome Measures

Primary Outcomes (1)

Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition
The incidence of exocrine pancreatic insufficiency will be evaluated that is based on hyperamylasemia, hyperlipasemia and fecal elastase-1 concentrations. multivariate logistic regression analyses are used to estimate the correlations between exocrine pancreatic insufficiency and clinical events and characteristics, which include APACHE II score, shock, hyperlactacidemia, respiratory failure, anemia, obesity, biliary sludge, hypertriglyceridemia, sepsis, cardiac arrest, cardiopulmonary bypass, severe head injury, acute stroke, post-neurosurgery, diabetes, inflammatory bowel disease, mechanical ventilation, continuous renal replacement therapy and medications such as propofol, valproate, metronidazole and morphine-derived drugs
From 2012-1 to 2012-12

Secondary Outcomes (1)

Effects of pancreatic enzyme supplementation on nutritional status and clinical outcomes in critically ill patients with sepsis
From 2013-1 to 2014-12