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AzTrials

Acute Necrotizing PancreatitisPhase 4NCT00995098

Early Enteral Nutrition for Severe Acute Pancreatitis

A Phase 4 study testing early enteral nutrition and Parenteral nutrition in people with Acute Necrotizing Pancreatitis, run by Sichuan Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Necrotizing Pancreatitis
What is being tested?
early enteral nutrition and Parenteral nutrition
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
Oct 2009to Oct 2010
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of severe acute pancreatitis
  • Consent informed

Who cannot join

  • Diabetes mellitus
  • Allergy for any ingredient of PN or EN regimen
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

Other trials in China

About this study

Official title: The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial

There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are inconclusive. The researchers of this study aim to investigate the impact of early enteral nutrition on the clinical outcomes of SAP patients.

Being tested
early enteral nutrition, Parenteral nutrition
Keywords
Acute severe pancreatitis, nutritional support, enteral nutrition, parenteral nutrition
Medical subject headings
Pancreatitis, Acute Necrotizing, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early enteral nutritionDietary supplement

    Also called Nutrison Fibre

    Enteral nutrition will be administered within 24 hours of admission through naso-jejunal tube and continue for 7 days after admission. Naso-jejunal tube will be set up by endoscopy. X-ray will be used to place the distal end of the feeding tube and EN would not start until the distal end of the feeding tube has been placed at the remote end of Treitz ligament. Standard enteral nutrition liquid regimen (Nutrison Fibre) will be used. Patients are targeted to receive calories for 25 kcal/kg/day and nitrogen for 0.2g/kg/day.

  • Parenteral nutritionDietary supplement

    Also called Lipovenoes(LCT/MCT fat emulsion, 20%), Novamin (11.4%)

    PN administration will start within 12 hours of admission and continue for 7 days after admission. Patients will receive calories for 25 kcal/kg and nitrogen for 0.2g/kg. Twenty percent of the calories will be provided by fat emulsion (LCT/MCT) and the remaining will be provided by dextrose. Nitrogen will be provided by balanced amino acids injection (Novamin). All PN components will be compounded into 3-liters bags under sterile conditions. Nutrition regimen will be administered through subclavian central venous catheter.

Study groups in NCT00995098
Study groupRoleWhat they receive
Early enteral nutritionExperimentalTwenty patient will be enrolled into this arm. Enteral nutrition administration will start within 24 hours after admission through naso-jejunal tube and continue for 7 days after admission.Naso-jejunal tube will be set up by endoscopy.
Receives: Dietary Supplement: early enteral nutrition
Control: Parenteral NutritionActive comparatorTwenty patient will be enrolled into this arm. PN administration will start within 24 hours after admission and continue for 7 days after admission.Parenteral nutrition will be administered through subclavian central venous catheter.
Receives: Dietary Supplement: Parenteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: Three months

Secondary outcomes (4)

  1. Pancreatic sepsis

    Measured: Three months

  2. Length of hospitalization

    Measured: From admission to discharge

  3. Operation ratio

    Measured: From admission to discharge

  4. Cost of hospitalization

    Measured: From admission to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJul 2010
  4. Study completionOct 2010

Resources

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
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995098
Sponsor's protocol ID
SAMS-080384
Status last verified
Nov 2010
First submitted
11 Oct 2009
Last updated
30 Nov 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Marik PE, Zaloga GP. Meta-analysis of parenteral nutrition versus enteral nutrition in patients with acute pancreatitis. BMJ. 2004 Jun 12;328(7453):1407. doi: 10.1136/bmj.38118.593900.55. Epub 2004 Jun 2.

    PubMed 15175229

  • Meier R, Beglinger C, Layer P, Gullo L, Keim V, Laugier R, Friess H, Schweitzer M, Macfie J; ESPEN Consensus Group. ESPEN guidelines on nutrition in acute pancreatitis. European Society of Parenteral and Enteral Nutrition. Clin Nutr. 2002 Apr;21(2):173-83. doi: 10.1054/clnu.2002.0543. No abstract available.

    PubMed 12056792

  • McClave SA, Chang WK, Dhaliwal R, Heyland DK. Nutrition support in acute pancreatitis: a systematic review of the literature. JPEN J Parenter Enteral Nutr. 2006 Mar-Apr;30(2):143-56. doi: 10.1177/0148607106030002143.

    PubMed 16517959

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing early enteral nutrition and Parenteral nutrition in people with Acute Necrotizing Pancreatitis, run by Sichuan Academy of Medical Sciences 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 2 inclusion and 3 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 30 Nov 2010. 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?

All cause mortality (time frame: Three months). 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 NCT00995098, which also lists 3 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 30 Nov 2010.

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