Acute PancreatitisPhase 4NCT01507766
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
A Phase 4 study testing early enteral nutrition and Delayed enteral nutrition in people with Acute Pancreatitis and Intra-abdominal Hypertension, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis, Intra-abdominal Hypertension
- What is being tested?
- early enteral nutrition and Delayed enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992
- Within 3 days from the onset of the disease
- Hemodynamics stable
Who cannot join
- Decompressive measures and enteral nutrition was performed before admission
- Ileus of lower digestive tract
- Pregnant pancreatitis
- Chronic organs dysfunction
- Immunodeficiency
Trial locations and contacts
1 site in 1 country.
China1 site
Department of SICU, Research Institute of General Surgery , Jinling Hospital
Nanjing, Jiangsu
About this study
As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP.
However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported.
Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.
- Conditions
- Acute Pancreatitis, Intra-abdominal Hypertension
- Being tested
- early enteral nutrition, Delayed enteral nutrition
- Keywords
- severe acute pancreatitis, intra-abdominal pressure, enteral nutrition
- Medical subject headings
- Pancreatitis, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early enteral nutritionDrug
The enteral nutrition was started within 48h after admission
Delayed enteral nutritionDrug
The enteral nutrition was started at the 8th day after admission
| Study group | Role | What they receive |
|---|---|---|
| Early enteral nutrition | Experimental | The enteral nutrition was started within 48h after admission Receives: Drug: early enteral nutrition |
| Delayed enteral nutrition | Active comparator | The enteral nutrition was started at the 8th day after admission Receives: Drug: Delayed enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral nutrition
The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
Measured: 14 days
Intra-abdominal pressure
The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
Measured: 14 days
Secondary outcomes (2)
Clinical outcome variables
Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels
Measured: 14 days
Immune parameters
IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Principal investigator, Jiakui Sun, Nanjing University School of Medicine
- Investigators
- Wei-qin Li, M.D., Study director, Jinlin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507766
- Sponsor's protocol ID
- 110-85
- Status last verified
- Nov 2012
- First submitted
- 3 Jan 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun JK, Li WQ, Ke L, Tong ZH, Ni HB, Li G, Zhang LY, Nie Y, Wang XY, Ye XH, Li N, Li JS. Early enteral nutrition prevents intra-abdominal hypertension and reduces the severity of severe acute pancreatitis compared with delayed enteral nutrition: a prospective pilot study. World J Surg. 2013 Sep;37(9):2053-60. doi: 10.1007/s00268-013-2087-5.
PubMed 23674254Sun JK, Mu XW, Li WQ, Tong ZH, Li J, Zheng SY. Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J Gastroenterol. 2013 Feb 14;19(6):917-22. doi: 10.3748/wjg.v19.i6.917.
PubMed 23431120
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01507766
- Acronym / sponsor ID
- 110-85
- Conditions
- Acute Pancreatitis, Intra-abdominal Hypertension
- Keywords
- severe acute pancreatitis, intra-abdominal pressure, enteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Jan 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.
As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP.
However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported.
Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early enteral nutrition | Experimental | Drug: early enteral nutritionThe enteral nutrition was started within 48h after admission |
| Delayed enteral nutrition | Active comparator | Drug: Delayed enteral nutritionThe enteral nutrition was started at the 8th day after admission |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992
- Within 3 days from the onset of the disease
- Hemodynamics stable
Key exclusion criteria (5 listed)
- Decompressive measures and enteral nutrition was performed before admission
- Ileus of lower digestive tract
- Pregnant pancreatitis
- Chronic organs dysfunction
- Immunodeficiency
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 |
|---|---|---|
| early enteral nutritionThe enteral nutrition was started within 48h after admission | Drug | Early enteral nutrition |
| Delayed enteral nutritionThe enteral nutrition was started at the 8th day after admission | Drug | Delayed enteral nutrition |
Primary outcome
Enteral nutrition
Time frame: 14 days
The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
Intra-abdominal pressure
Time frame: 14 days
The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
2 secondary outcomes
Clinical outcome variables
Time frame: 14 days
Immune parameters
Time frame: 14 days
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 16 Nov 2012.
- Derived from this study: PubMed 23674254Sun JK, Li WQ, Ke L, Tong ZH, Ni HB, Li G, Zhang LY, Nie Y, Wang XY, Ye XH, Li N, Li JS. Early enteral nutrition prevents intra-abdominal hypertension and reduces the severity of severe acute pancreatitis compared with delayed enteral nutrition: a prospective pilot study. World J Surg. 2013 Sep;37(9):2053-60. doi: 10.1007/s00268-013-2087-5.
- Derived from this study: PubMed 23431120Sun JK, Mu XW, Li WQ, Tong ZH, Li J, Zheng SY. Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J Gastroenterol. 2013 Feb 14;19(6):917-22. doi: 10.3748/wjg.v19.i6.917.
Related trials for Acute Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
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.
Wei-qin Li, M.D. study director
Jinlin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early enteral nutrition and Delayed enteral nutrition in people with Acute Pancreatitis and Intra-abdominal Hypertension, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Enteral nutrition (time frame: 14 days). The study lists 2 primary outcomes in all. 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 NCT01507766, which also lists 2 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 16 Nov 2012.