Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shanghai 10th People's Hospital
Sponsor:
Collaborators:
Tongji Hospital
Shanghai 9th People's Hospital
Information provided by (Responsible Party):
Sheng Wang MD PhD, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT01753024
First received: December 16, 2012
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Critical Illness
Sepsis
Diabetes
Cardiac Arrest
Acute Renal Failure
Shock
Dietary Supplement: Enteral nutrition (EN)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: The Incidence of Pancreatic Exocrine Insufficiency and the Benefits of Pancreatic Enzyme Supplementation in Critically Ill Adult Patients

Resource links provided by NLM:


Further study details as provided by Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition [ Time Frame: From 2012-1 to 2012-12 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Effects of pancreatic enzyme supplementation on nutritional status and clinical outcomes in critically ill patients with sepsis [ Time Frame: From 2013-1 to 2014-12 ] [ Designated as safety issue: No ]

    The incidence of exocrine pancreatic insufficiency and the nutritional status are evaluated by fecal elastase-1 concentrations before pancreatic enzyme supplementation therapy is applied.

    Patients are assigned into two groups randomly, the control group is only receiving enteral nutrition without the addition of pancreatic enzyme(CREON), and the PEST group is given both enteral nutrition and pancreatic enzyme supplementation therapy at the same time.

    Following two weeks of corresponding treatments, the nutritional status and clinical outcomes are documented in both groups for statistical analysis.



Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 1200
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sepsis-PEST
septic patients with enteral nutrition and pancreatic enzyme supplementation therapy
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
Sepsis-NPEST
Septic patients with enteral nutrition only
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
DM-PEST
Diabetic patients with enteral nutrition and pancreatic enzyme supplementation therapy
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
DM-NPEST
Diabetic patients with enteral nutrition only
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
PCAS-PEST
Patients suffering from cardiac arrest receive both enteral nutrition and pancreatic enzyme supplementation therapy
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
PCAS-NPEST
Patients suffering from cardiac arrest receive enteral nutrition only
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
ARF-PEST
Patients with acute renal failure receive both enteral nutrition and pancreatic enzyme supplementation therapy
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition
ARF-NPEST
Patients with acute renal failure receive enteral nutrition only
Dietary Supplement: Enteral nutrition (EN)
All patients enrolled in this study must carry out nutritional support by enteral nutrition

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753024

Contacts
Contact: Li Jie Ma, MD, MSc 86-21-66307153 believablemyth@126.com
Contact: Yu Hao Liu, MD, MSc 86-21-66307153 lyh-7906@163.com

Locations
China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Lijie Ma, MD, MSc    86-21-66307153    believablemyth@126.com   
Contact: Yuhao Liu, MD, MSc    86-21-66307153    lyh-7906@163.com   
Principal Investigator: Sheng Wang, MD, PhD         
Sub-Investigator: Cheng Jin Gao, MD, PhD         
Sub-Investigator: Feng Zhou, MD, PhD         
Sub-Investigator: Gang Yu Zhuang, MD, MSc         
Tongji Hospital Recruiting
Shanghai, Shanghai, China, 200065
Contact: Lei Zhang, MD    86 13817869671    zhanglei558@hotmail.com   
Contact: Guangjian Chen, MD, MSc    86 15921979008      
Sponsors and Collaborators
Shanghai 10th People's Hospital
Tongji Hospital
Shanghai 9th People's Hospital
Investigators
Study Director: Sheng Wang, MD, PhD Shanghai 10th People's Hospital
Principal Investigator: Yu G Zhuang, MD, MSc Shanghai 10th People's Hospital
Principal Investigator: Li J Ma, MD, MSc Shanghai 10th People's Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheng Wang MD PhD, Associate professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01753024     History of Changes
Other Study ID Numbers: STPH-ICU-002
Study First Received: December 16, 2012
Last Updated: September 28, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai 10th People's Hospital:
exocrine pancreatic insufficiency
fecal elastase-1
amylase
lipase
critical illness
enteral nutrition
malnutrition
sepsis
diabetes
hyperlactacidemia
hemodialysis
mechanical ventilation

Additional relevant MeSH terms:
Renal Insufficiency
Critical Illness
Heart Arrest
Acute Kidney Injury
Exocrine Pancreatic Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 01, 2014