NCT03612206

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

July 18, 2018

Last Update Submit

July 27, 2018

Conditions

Critical IllnessEnteral NutritionInflammation

Outcome Measures

Primary Outcomes (2)

  • 28-day mortality

    The number of survival and non-survival patients 28 days after inclusion

    14 months

  • Intestinal barrier function within one week

    The measurement of serum d-lactate was applied to evaluate the intestinal barrier function

    14 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tao G, Min-Hua C, Feng-Chan X, Yan C, Ting S, Wei-Qin L, Wen-Kui Y. Changes of plasma acetylcholine and inflammatory markers in critically ill patients during early enteral nutrition: A prospective observational study. J Crit Care. 2019 Aug;52:219-226. doi: 10.1016/j.jcrc.2019.05.008. Epub 2019 May 10.

    PMID: 31108325DERIVED

MeSH Terms

Conditions

Critical IllnessInflammation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 2, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

August 2, 2018

Record last verified: 2018-07