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Critical Illness | Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: All critically ill patients who are able to receive early enteral nutrition and estimated to stay in ICU at least four days Exclusion Criteria: age under 18 or over 80 years, pregnancy or breastfeeding, known exocrine pancreatic insufficiency due to pancreatitis, unresectable pancreatic cancer, cystic fibrosis, celiac disease, Zollinger-Ellison syndrome, pancreatectomy, gastrectomy and medications of somatostatin or aprotinin that directly influence pancreatic exocrine function

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Sepsis

Diabetes

Cardiac Arrest

Acute Renal Failure

Shock

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Enteral nutrition (EN)All patients enrolled in this study must carry out nutritional support by enteral nutrition

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sepsis-PESTseptic patients with enteral nutrition and pancreatic enzyme supplementation therapy

Sepsis-NPESTSeptic patients with enteral nutrition only

DM-PESTDiabetic patients with enteral nutrition and pancreatic enzyme supplementation therapy

DM-NPESTDiabetic patients with enteral nutrition only

PCAS-PESTPatients suffering from cardiac arrest receive both enteral nutrition and pancreatic enzyme supplementation therapy

PCAS-NPESTPatients suffering from cardiac arrest receive enteral nutrition only

ARF-PESTPatients with acute renal failure receive both enteral nutrition and pancreatic enzyme supplementation therapy

ARF-NPESTPatients with acute renal failure receive enteral nutrition only

Study Status

Unknown status

Start Date: January 2012

Completed Date: December 2014

Phase:

Type: Observational [Patient Registry]

Design:

Primary Outcome: Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition

Secondary Outcome: Effects of pancreatic enzyme supplementation on nutritional status and clinical outcomes in critically ill patients with sepsis

Study sponsors, principal investigator, and references

Principal Investigator: Sheng Wang, MD, PhD

Lead Sponsor: Shanghai 10th People's Hospital

Collaborator: Tongji Hospital

More information:https://clinicaltrials.gov/show/NCT01753024

Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nob├ęcourt E, Boitard C. Pancreatic exocrine function in patients with diabetes. Diabet Med. 2012 Aug;29(8):1047-54. doi: 10.1111/j.1464-5491.2012.03597.x.

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