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?
Acute Renal Failure
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
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
Start Date: January 2012
Completed Date: December 31, 2015
Type: Observational [Patient Registry]
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
Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nobécourt 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.