Prevalence and Outcome of Hypermetabolism in Initial Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study

June 12, 2014 updated by: Chao Wu, Nanjing University School of Medicine

Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study

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

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210093
        • Recruiting
        • Nanjing University School of Medicine
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Length of stay in ICU
Time Frame: Length of ICU stay within 60 days
Length of ICU stay within 60 days

Collaborators and Investigators

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

Sponsor

Nanjing University School of Medicine

Collaborators

Jinling Hospital, China

Investigators

  • Study Director: Xinying Wang, MD, Nanjing University School of Medicine

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

December 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 1, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013KLY-022

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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