NCT02002676

Brief Summary

Patients in critical illness frequently present hypermetabolism, which can extremely increase the rest energy expenditure(REE). We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

November 26, 2013

Last Update Submit

June 12, 2014

Conditions

Keywords

rest energy expenditure,critical ill, outcome

Outcome Measures

Primary Outcomes (1)

  • Mortality rate of 28 days

    From ICU admission to 28th days of observation

Secondary Outcomes (1)

  • Incidence of Multiple Organ Dysfunction Syndrome(MODS)in 60 days

    From ICU admission to 60th days of observation

Other Outcomes (1)

  • Length of stay in ICU

    Length of ICU stay within 60 days

Eligibility Criteria

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

Patients who admitted ICU with hypermatebolic status, which the results of indirect calorimetry show that the actual rest energy expenditure values are remarkably higher than the predicted ones.

You may qualify if:

  • Older than 18 year.
  • APACHEⅡ score≥8

You may not qualify if:

  • Hypercortisolism
  • Thyroid disease
  • Tracheoesophageal fistula
  • FiO2\>60 or PEEP\>12cm H2O in mechanical ventilate
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing University School of Medicine

Nanjing, Jiangsu, 210093, China

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Xinying Wang, MD

    Nanjing University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.candidate

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 6, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations