NCT01834430

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3

Status
completed

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

February 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

April 7, 2013

Last Update Submit

April 15, 2013

Conditions

Severe Acute Pancreatitis PatientsDuodenal FistulaInflammatory Intestinal Obstruction

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    28 days

Secondary Outcomes (1)

  • organ failure

    7 days

Other Outcomes (1)

  • inflammatory markers

    7 days

Study Arms (2)

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.

Dietary Supplement: enteral nutrition

parenteral nutrient group

NO INTERVENTION

Interventions

enteral nutritionDIETARY_SUPPLEMENT
EN group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 7, 2013

First Posted

April 17, 2013

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Last Updated

April 17, 2013

Record last verified: 2013-04