Prevalence and Outcome of Hypermetabolism in Initial Prev... | NCT02002676

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Nov 26, 2013

First Submission Date that Met QC Criteria

Dec 1, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2014

Last Update Posted Date

Jun 13, 2014Estimated

Name	Class
Jinling Hospital, China	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

This study focuses on the early changes of REE of critical ill patients when they admitted to ICU.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality rate of 28 days		From ICU admission to 28th days of observation

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Multiple Organ Dysfunction Syndrome（MODS）in 60 days		From ICU admission to 60th days of observation

Other Outcomes

Measure	Description	Time Frame
Length of stay in ICU		Length of ICU stay within 60 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 year.
APACHEⅡ score≥8

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xinying Wang, MD	Nanjing University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing University School of Medicine	Recruiting	Nanjing	Jiangsu	210093	China

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Chao Wu, Ph.D.candidate, Nanjing University School of Medicine

Unposted Events

Type	Date	Date Unknown
Release	Jul 5, 2014
Reset	Jul 31, 2014

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Jul 5, 2014

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D018805	Sepsis
D012772	Shock, Septic

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock