Severe Acute Pancreatitis PatientsPhase 3NCT01834430
Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
A Phase 3 study testing enteral nutrition in people with Severe Acute Pancreatitis Patients and Duodenal Fistula, run by Nanjing PLA General Hospital.
Trial summary
Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Acute Pancreatitis Patients, Duodenal Fistula, Inflammatory Intestinal Obstruction
- What is being tested?
- enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2012
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having a fasting time of more than 14 days
- American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.
Who cannot join
- chronic renal failure (peritoneal or hemodialysis or creatinine > 2.5 mg/dl)
- history of chronic obstructive pulmonary disease
- hepatic dysfunction or cirrhosis or a bilirubin value > 3 mg/dl
- metabolic diseases,severe anemia
- blood coagulation dysfunction
- pregnancy lactation
- history of psychiatric illness
- patients underwent immunosuppressive therapy
About this study
Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.
- Being tested
- enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| EN group | Experimental | The EN group gradually restored enteral nutrition, while the PN group continued to receive parenteral nutrition treatment. Both groups received between 20 to 25 kcal/kg/day and 1.5 g/kg/day of protein. Because of the low volume, concentration, and calorie amount, on the first day, tube feeding utilized 500 ml with the speed of 30 ~ 50 ml/h. On the second day, tube feeding utilized 1000 ml with the speed of 60 ~ 80 ml/h. On the third day, tube feeding utilized 1500 ~ 2000 ml with the speed of 100 ~ 120 ml/h. If enteral nutrition could not meet a patient's caloric requirements, PN supplement was started on the fourth day. The required calories and protein for each individual in the two groups was assumed to be achieved after three days of therapy. The PN group continued to receive parenteral nutrition. Receives: Dietary Supplement: enteral nutrition |
| parenteral nutrient group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days
Secondary outcomes (1)
organ failure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Pancreatitis PatientsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834430
- Sponsor's protocol ID
- 2009NLY059
- Status last verified
- Apr 2013
- First submitted
- 7 Apr 2013
- Last updated
- 17 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
- ClinicalTrials.gov ID
- NCT01834430
- Acronym / sponsor ID
- 2009NLY059
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 17 Apr 2013 (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.
Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN group | Experimental | Dietary Supplement: enteral nutritionThe EN group gradually restored enteral nutrition, while the PN group continued to receive parenteral nutrition treatment. Both groups received between 20 to 25 kcal/kg/day and 1.5 g/kg/day of protein. Because of the low volume, concentration, and calorie amount, on the first day, tube feeding utilized 500 ml with the speed of 30 ~ 50 ml/h. On the second day, tube feeding utilized 1000 ml with the speed of 60 ~ 80 ml/h. On the third day, tube feeding utilized 1500 ~ 2000 ml with the speed of 100 ~ 120 ml/h. If enteral nutrition could not meet a patient's caloric requirements, PN supplement was started on the fourth day. The required calories and protein for each individual in the two groups was assumed to be achieved after three days of therapy. The PN group continued to receive parenteral nutrition. |
| parenteral nutrient group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- having a fasting time of more than 14 days
- American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.
Key exclusion criteria (8 listed)
- chronic renal failure (peritoneal or hemodialysis or creatinine > 2.5 mg/dl)
- history of chronic obstructive pulmonary disease
- hepatic dysfunction or cirrhosis or a bilirubin value > 3 mg/dl
- metabolic diseases,severe anemia
- blood coagulation dysfunction
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 | Dietary supplement | EN group |
Primary outcome
all cause mortality
Time frame: 28 days
1 secondary outcome
organ failure
Time frame: 7 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 17 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing enteral nutrition in people with Severe Acute Pancreatitis Patients and Duodenal Fistula, run by Nanjing PLA General Hospital.
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 2 inclusion and 8 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
all cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2013.