Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients

July 27, 2018 updated by: Gao Tao, Nanjing PLA General Hospital
Early enteral nutrition(EEN) is an important treatment for critical ill patients and attenuate systemic inflammation, but the mechanisms are not clear. Thus the investigator conducted this study to observe if EEN affects systemic inflammation though regulation of blood acetylcholine

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population mainly includes patients who suffered severe complications after surgery or severe trauma

Description

Inclusion Criteria:

  • initiating enteral nutrition within the first 24-48h after intensive care unit (ICU) admission
  • age more than 18 years
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score >8

Exclusion Criteria:

  • not expected to survive 24 hours
  • pregnancy
  • any terminal stage disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 14 months
The number of survival and non-survival patients 28 days after inclusion
14 months
Intestinal barrier function within one week
Time Frame: 14 months
The measurement of serum d-lactate was applied to evaluate the intestinal barrier function
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016NLYZDRC022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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