NCT02000323

Brief Summary

to compare different time points for enteral nutrition in SAP patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2013

Enrollment Period

4.1 years

First QC Date

November 5, 2013

Last Update Submit

November 26, 2013

Conditions

Pancreatitis

Keywords

pancreatitisenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • mortality

    the rate of patients died

    28days

Secondary Outcomes (2)

  • operation rate

    2 months

  • fulfilling enteral nutrition target（≥25Kcal/kg/day）

    7 days

Other Outcomes (1)

  • inta-abdominal infection

    2 months

Study Arms (2)

early enteral nutrition

ACTIVE COMPARATOR

Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Standard enteral nutrition liquid regimen （Peptisorb Liquid）will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

Other: early enteral nutrition

modified early enteral nutrition

ACTIVE COMPARATOR

Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through Naso-gastro-Jejunal tube until 2 or more followed requirements were met mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure \<20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

Other: modified early enteral nutrition

Interventions

early enteral nutritionOTHER

Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. • After catharsis, Standard enteral nutrition liquid regimen will be used step by step. Patients are targeted to receive calories for 25 kcal/kg/day. nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day

early enteral nutrition
modified early enteral nutritionOTHER

Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through nasojejunal tube until 2 or more followed requirements were meted (mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure \<20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

modified early enteral nutrition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
  • Onset of abdominal pain within \<=72h before admission
  • moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff

You may not qualify if:

  • \. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis
  • chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. Pre-existing disease with life expectancy \< 3 months 7.receive parenteral nutrition or enteral nutrition before admitting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • Ong JP, Fock KM. Nutritional support in acute pancreatitis. J Dig Dis. 2012 Sep;13(9):445-52. doi: 10.1111/j.1751-2980.2012.00611.x.

    PMID: 22908969RESULT

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Qiang en Mao, phd

    Emergency intensive care unit of Ruijin Hospital

    STUDY DIRECTOR

  • Wen xu, Master

    doctor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Er chen, PHD

CONTACT

64370045chenerzhen@hotmail.com

qiang En mao

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prefessor

Study Record Dates

First Submitted

November 5, 2013

First Posted

December 4, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2016

Study Completion

August 1, 2017

Last Updated

December 4, 2013

Record last verified: 2013-11

Locations

CN(1)