Critical IllnessNCT01753024
Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients
An observational study of Critical Illness and Sepsis, run by Shanghai 10th People's Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Sepsis, Diabetes
- What is being tested?
- Enteral nutrition (EN)
- How many people
- 362 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2012to 31 Dec 2015
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All critically ill patients who are able to receive early enteral nutrition and estimated to stay in ICU at least four days
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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, Sepsis, Diabetes, Cardiac Arrest, Acute Renal Failure, Shock
- Being tested
- Enteral nutrition (EN)
- Keywords
- exocrine pancreatic insufficiency, fecal elastase-1, amylase, lipase, critical illness, enteral nutrition, malnutrition, sepsis, diabetes, hyperlactacidemia, hemodialysis, mechanical ventilation
- Medical subject headings
- Critical Illness, Sepsis, Diabetes Mellitus, Heart Arrest, Acute Kidney Injury, Shock, Exocrine Pancreatic Insufficiency, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutrition (EN)Dietary supplement
All patients enrolled in this study must carry out nutritional support by enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Sepsis-PEST | septic patients with enteral nutrition and pancreatic enzyme supplementation therapy Receives: Dietary Supplement: Enteral nutrition (EN) | |
| Sepsis-NPEST | Septic patients with enteral nutrition only Receives: Dietary Supplement: Enteral nutrition (EN) | |
| DM-PEST | Diabetic patients with enteral nutrition and pancreatic enzyme supplementation therapy Receives: Dietary Supplement: Enteral nutrition (EN) | |
| DM-NPEST | Diabetic patients with enteral nutrition only Receives: Dietary Supplement: Enteral nutrition (EN) | |
| PCAS-PEST | Patients suffering from cardiac arrest receive both enteral nutrition and pancreatic enzyme supplementation therapy Receives: Dietary Supplement: Enteral nutrition (EN) | |
| PCAS-NPEST | Patients suffering from cardiac arrest receive enteral nutrition only Receives: Dietary Supplement: Enteral nutrition (EN) | |
| ARF-PEST | Patients with acute renal failure receive both enteral nutrition and pancreatic enzyme supplementation therapy Receives: Dietary Supplement: Enteral nutrition (EN) | |
| ARF-NPEST | Patients with acute renal failure receive enteral nutrition only Receives: Dietary Supplement: Enteral nutrition (EN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition
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
Measured: From 2012-1 to 2012-12
Secondary outcomes (1)
Effects of pancreatic enzyme supplementation on nutritional status and clinical outcomes in critically ill patients with sepsis
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.
Measured: From 2013-1 to 2014-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Sheng Wang MD PhD, Shanghai 10th People's Hospital
- Investigators
- Sheng Wang, MD, PhD, Study director, Shanghai 10th People's HospitalYu G Zhuang, MD, MSc, Principal investigator, Shanghai 10th People's HospitalLi J Ma, MD, MSc, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753024
- Sponsor's protocol ID
- STPH-ICU-001
- Status last verified
- Sep 2018
- First submitted
- 16 Dec 2012
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nobecourt 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.
PubMed 22273174Teichmann J, Riemann JF, Lange U. Prevalence of exocrine pancreatic insufficiency in women with obesity syndrome: assessment by pancreatic fecal elastase 1. ISRN Gastroenterol. 2011;2011:951686. doi: 10.5402/2011/951686. Epub 2011 Nov 3.
PubMed 22111014Wier HA, Kuhn RJ. Pancreatic enzyme supplementation. Curr Opin Pediatr. 2011 Oct;23(5):541-4. doi: 10.1097/MOP.0b013e32834a1b33.
PubMed 21799412Leeds JS, Oppong K, Sanders DS. The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011 May 31;8(7):405-15. doi: 10.1038/nrgastro.2011.91.
PubMed 21629239Ferrie S, Graham C, Hoyle M. Pancreatic enzyme supplementation for patients receiving enteral feeds. Nutr Clin Pract. 2011 Jun;26(3):349-51. doi: 10.1177/0884533611405537. Epub 2011 Apr 20.
PubMed 21508176Dominguez-Munoz JE. Pancreatic exocrine insufficiency: diagnosis and treatment. J Gastroenterol Hepatol. 2011 Mar;26 Suppl 2:12-6. doi: 10.1111/j.1440-1746.2010.06600.x.
PubMed 21323992Kuhn RJ, Gelrud A, Munck A, Caras S. CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. Adv Ther. 2010 Dec;27(12):895-916. doi: 10.1007/s12325-010-0085-7. Epub 2010 Nov 15.
PubMed 21086085Griesche-Philippi J, Otto J, Schworer H, Maisonneuve P, Lankisch PG. Exocrine pancreatic function in patients with end-stage renal disease. Clin Nephrol. 2010 Dec;74(6):457-64. doi: 10.5414/cnp74457.
PubMed 21084049Ockenga J. Importance of nutritional management in diseases with exocrine pancreatic insufficiency. HPB (Oxford). 2009 Dec;11 Suppl 3(Suppl 3):11-5. doi: 10.1111/j.1477-2574.2009.00134.x.
PubMed 20495627Hardt PD, Mayer K, Ewald N. Exocrine pancreatic involvement in critically ill patients. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):168-74. doi: 10.1097/MCO.0b013e328322437e.
PubMed 19202388Senkal M, Ceylan B, Deska T, Marpe B, Geier B. Exocrine pancreas disfunction in severely traumatised patients and early enteral nutrition. Ulus Travma Acil Cerrahi Derg. 2008 Jan;14(1):34-9.
PubMed 18306065Denz C, Siegel L, Lehmann KJ, Dagorn JC, Fiedler F. Is hyperlipasemia in critically ill patients of clinical importance? An observational CT study. Intensive Care Med. 2007 Sep;33(9):1633-6. doi: 10.1007/s00134-007-0668-1. Epub 2007 May 12.
PubMed 17497124Nys M, Venneman I, Deby-Dupont G, Preiser JC, Vanbelle S, Albert A, Camus G, Damas P, Larbuisson R, Lamy M. Pancreatic cellular injury after cardiac surgery with cardiopulmonary bypass: frequency, time course and risk factors. Shock. 2007 May;27(5):474-81. doi: 10.1097/shk.0b013e31802b65f8.
PubMed 17438451Serrano N. Increased lipase plasma levels in ICU patients: when are they critical? Chest. 2005 Jan;127(1):7-10. doi: 10.1378/chest.127.1.7. No abstract available.
PubMed 15653954Wang S, Ma L, Zhuang Y, Jiang B, Zhang X. Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition. Crit Care. 2013 Aug 7;17(4):R171. doi: 10.1186/cc12850.
PubMed 23924602
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Pancreatic Exocrine Insufficiency and the Benefits of Pancreatic Enzyme Supplementation in Critically Ill Adult Patients
- ClinicalTrials.gov ID
- NCT01753024
- Acronym / sponsor ID
- STPH-ICU-001
- Conditions
- Critical Illness, Sepsis, Diabetes, Cardiac Arrest, Acute Renal Failure, Shock
- Keywords
- exocrine pancreatic insufficiency, fecal elastase-1, amylase, lipase, critical illness, enteral nutrition, malnutrition, sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- Jan 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sepsis-PEST | – | Dietary Supplement: Enteral nutrition (EN)septic patients with enteral nutrition and pancreatic enzyme supplementation therapy |
| Sepsis-NPEST | – | Dietary Supplement: Enteral nutrition (EN)Septic patients with enteral nutrition only |
| DM-PEST | – | Dietary Supplement: Enteral nutrition (EN)Diabetic patients with enteral nutrition and pancreatic enzyme supplementation therapy |
| DM-NPEST | – | Dietary Supplement: Enteral nutrition (EN)Diabetic patients with enteral nutrition only |
| PCAS-PEST | – | Dietary Supplement: Enteral nutrition (EN)Patients suffering from cardiac arrest receive both enteral nutrition and pancreatic enzyme supplementation therapy |
| PCAS-NPEST | – | Dietary Supplement: Enteral nutrition (EN)Patients suffering from cardiac arrest receive enteral nutrition only |
| ARF-PEST | – | Dietary Supplement: Enteral nutrition (EN)Patients with acute renal failure receive both enteral nutrition and pancreatic enzyme supplementation therapy |
| ARF-NPEST | – | Dietary Supplement: Enteral nutrition (EN)Patients with acute renal failure receive enteral nutrition only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients who are able to receive early enteral nutrition and estimated to stay in ICU at least four days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutrition (EN)All patients enrolled in this study must carry out nutritional support by enteral nutrition | Dietary supplement | ARF-NPEST, ARF-PEST, DM-NPEST, DM-PEST, PCAS-NPEST, PCAS-PEST, Sepsis-NPEST, Sepsis-PEST |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 22273174Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nobecourt 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.
- Background: PubMed 22111014Teichmann J, Riemann JF, Lange U. Prevalence of exocrine pancreatic insufficiency in women with obesity syndrome: assessment by pancreatic fecal elastase 1. ISRN Gastroenterol. 2011;2011:951686. doi: 10.5402/2011/951686. Epub 2011 Nov 3.
- Background: PubMed 21799412Wier HA, Kuhn RJ. Pancreatic enzyme supplementation. Curr Opin Pediatr. 2011 Oct;23(5):541-4. doi: 10.1097/MOP.0b013e32834a1b33.
- Background: PubMed 21629239Leeds JS, Oppong K, Sanders DS. The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011 May 31;8(7):405-15. doi: 10.1038/nrgastro.2011.91.
- Background: PubMed 21508176Ferrie S, Graham C, Hoyle M. Pancreatic enzyme supplementation for patients receiving enteral feeds. Nutr Clin Pract. 2011 Jun;26(3):349-51. doi: 10.1177/0884533611405537. Epub 2011 Apr 20.
- Background: PubMed 21323992Dominguez-Munoz JE. Pancreatic exocrine insufficiency: diagnosis and treatment. J Gastroenterol Hepatol. 2011 Mar;26 Suppl 2:12-6. doi: 10.1111/j.1440-1746.2010.06600.x.
- Background: PubMed 21086085Kuhn RJ, Gelrud A, Munck A, Caras S. CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. Adv Ther. 2010 Dec;27(12):895-916. doi: 10.1007/s12325-010-0085-7. Epub 2010 Nov 15.
- Background: PubMed 21084049Griesche-Philippi J, Otto J, Schworer H, Maisonneuve P, Lankisch PG. Exocrine pancreatic function in patients with end-stage renal disease. Clin Nephrol. 2010 Dec;74(6):457-64. doi: 10.5414/cnp74457.
- Background: PubMed 20495627Ockenga J. Importance of nutritional management in diseases with exocrine pancreatic insufficiency. HPB (Oxford). 2009 Dec;11 Suppl 3(Suppl 3):11-5. doi: 10.1111/j.1477-2574.2009.00134.x.
- Background: PubMed 19202388Hardt PD, Mayer K, Ewald N. Exocrine pancreatic involvement in critically ill patients. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):168-74. doi: 10.1097/MCO.0b013e328322437e.
- Background: PubMed 18306065Senkal M, Ceylan B, Deska T, Marpe B, Geier B. Exocrine pancreas disfunction in severely traumatised patients and early enteral nutrition. Ulus Travma Acil Cerrahi Derg. 2008 Jan;14(1):34-9.
- Background: PubMed 17497124Denz C, Siegel L, Lehmann KJ, Dagorn JC, Fiedler F. Is hyperlipasemia in critically ill patients of clinical importance? An observational CT study. Intensive Care Med. 2007 Sep;33(9):1633-6. doi: 10.1007/s00134-007-0668-1. Epub 2007 May 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng Wang, MD, PhD study director
Shanghai 10th People's Hospital
Yu G Zhuang, MD, MSc principal investigator
Shanghai 10th People's Hospital
Li J Ma, MD, MSc principal investigator
Shanghai 10th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sepsis, run by Shanghai 10th People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening and risk factors of exocrine pancreatic insufficiency in critically ill adult patients receiving enteral nutrition (time frame: From 2012-1 to 2012-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753024, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.