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Clinical Trials/NCT01834430
NCT01834430CompletedPhase 3

Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Nanjing PLA General Hospital0 sites45 target enrollmentStarted: February 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
45
Primary Endpoint
all cause mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

all cause mortality

Time Frame: 28 days

Secondary Outcomes

  • organ failure(7 days)

Investigators

Sponsor
Nanjing PLA General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gao Tao

Clinical Professor

Nanjing PLA General Hospital

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