Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients
Condition: Critical Illness; Sepsis; Diabetes; Cardiac Arrest; Acute Renal Failure; Shock
MeSH terms: Exocrine Pancreatic Insufficiency; Acute Kidney Injury; Critical Illness
Study type: Observational [Patient Registry]

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.
    

Detailed description: 
      Critically ill patients who is able to receive early enteral nutrition and estimated to stay
      in ICU at least four days are considered to enroll into this study. Exclusion criteria are
      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.

      Informed consent documents are signed by immediate family members of the recruited patients.
      All study procedures are performed in accordance with the institutional guidelines for the
      conduct of research on human beings and approved by the Human Ethics Committee of Shanghai
      Tenth People's Hospital.

      Once the enrolled patients are admitted to the ICU, they are inserted either a nasogastric
      tube or a nasojejunal tube guided by electronic gastroscope according to the expected feeding
      time, and the position of feeding tubes is confirmed by plain abdominal radiograph. Enteral
      nutrition will be initiated at a rate of 25 ml/h within 24h of admission, and the infusion
      rate increases steadily until the prescribed nutritional requirements are achieved within 3
      days. Daily nutritional requirements are calculated mainly based on the patient's body mass
      index.

      During the study, the details of each patient such as age, sex, BMI, admission diagnosis, and
      Acute Physiology and Chronic Health Evaluation II score are collected. All clinical
      characteristics that may cause pancreatic damage, including shock (systolic blood pressure <
      90 mmHg), tissue hypoxia (serum lactate > 2 mmol/L), respiratory failure (PaO2 < 60 mmHg),
      anemia (hemoglobin < 90 g/L), obesity (BMI > 30 kg/m2), biliary sludge (total bilirubin >
      17.5 μmol/L), hypertriglyceridemia (> 1.7 mmol/L), sepsis, cardiac arrest, cardiopulmonary
      bypass (CPB), severe head injury, acute stroke, post-neurosurgery, diabetes, inflammatory
      bowel disease (IBS), mechanical ventilation and continuous renal replacement therapy (CRRT)
      are recorded prospectively. Medications such as propofol, valproate, metronidazole and
      morphine-derived drugs, which are applied for more than 24 h and might induce pancreatic
      damage, are also documented. Arterial blood samples are taken 3 days after admission to
      determine biochemical parameters. Stool samples are collected 3-5 days after the beginning of
      enteral nutrition and frozen at -20℃ until analysis. Some patients will undergo CT scanning
      and magnetic resonance cholangio-pancreatography (MRCP)to acquire histological evidence of
      exocrine pancreatic insufficiency.
    

Intervention name(s): Enteral nutrition (EN)
Intervention type(s): Dietary Supplement
Intervention description(s): All patients enrolled in this study must carry out nutritional support by enteral nutrition
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All critically ill patients who are able to receive early enteral nutrition and estimated
        to stay in ICU at least four days
      
Biospecimen description: 
      Blood samples: lactate, hemoglobin, total bilirubin, trypsin, Vit D, etc. Stool samples: 24h
      fecal fat; fetal elastase-1; Fecal chymotrypsin. Nutrition status: BMI, weight loss,
      biomarkers such as albumin and prealbumin, etc.

      Radiological assessments: MRCP & CT scanning.
    
Keywords: exocrine pancreatic insufficiency; fecal elastase-1; amylase; lipase; critical illness; enteral nutrition; malnutrition; sepsis; diabetes; hyperlactacidemia; hemodialysis; mechanical ventilation