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

September 4, 2018 updated by: Sheng Wang MD PhD, Shanghai 10th People's Hospital

The Incidence of Pancreatic Exocrine Insufficiency and the Benefits of Pancreatic Enzyme Supplementation in Critically Ill Adult Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

362

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, Shanghai, China, 200065
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition
Time Frame: From 2012-1 to 2012-12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
From 2013-1 to 2014-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

Tongji Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

December 16, 2012

First Submitted That Met QC Criteria

December 16, 2012

First Posted (Estimate)

December 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STPH-ICU-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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