Skip to main content
OpenTrials
Completed

NCT Number: NCT01834430

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Acute Pancreatitis Patients Duodenal Fistula Inflammatory Intestinal Obstruction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Nutrition

Dietary Supplement

Primary outcomes

  1. all cause mortality

    Time frame: 28 days

Secondary outcomes

  1. organ failure

    Time frame: 7 days

Other outcomes

  1. inflammatory markers

    Time frame: 7 days

    white blood cell count, C reactive protein(CRP), pro-inflammatory cytokines (TNF-a,IL-1,IL-6), and anti-inflammatory cytokines (IL-4, IL-10)

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
First posted
Apr 17, 2013
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.