- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082326
The CCUS Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
July 28, 2017 updated by: tongjuan ZOU, West China Hospital
The Critical Care Ultrasound Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
Shock is a common condition in critical care unit (ICU).
It is extremely important that the patient accepts early goal-directed therapy (EGDT) treatment in the early stage of shock.
However, several studies failed to demonstrate that the well used variables such as CVP and others could direct to a better treatment.
In recent years, critical care ultrasound (CCUS) has been respected as a reliable noninvasive tool and widely used in ICU practice.
With CCUS the investigators can accurately acquired the detailed information of the characteristic of the hemodynamics and lung pathology (the systole and diastole function, volume status, valve insufficiency, lung, edema, consolidation, and pleural effusion, etc.).
To the investigators knowledge, there is no study investigating the epidemic of such ultrasonic variables and its value to predict to outcome.
The aim of this study is to investigate the epidemic and the prognostic value of CCUS Based Characteristic of Hemodynamic and Lung pathology in Early Stage of Shock in patients admitted in ICU.
Study Overview
Status
Completed
Conditions
Detailed Description
Adult patients who admitted to the intensive care unit of West China hospital of sichuan university with shock from April 2016 to April 2017 enrolled.
Study Type
Observational
Enrollment (Actual)
181
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
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Sichuan
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Chengde, Sichuan, China, 610041
- West China Hospital,Sichuan University
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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
Shock patients with 6 hours admitted in ICU in west china hospital of sichuan university.
Description
Inclusion Criteria:
- SBP<90 mm Hg or MAP <70 mm Hg or SBP decrease >40mmHg or need vasoactive drugs;
- Skin that is cold and clammy, capillary refill time >4.5s, urine output of <0.5ml/Kg.hr and lactate>2mmol/L;
- SHOCK presented within 6 hr.
Exclusion Criteria:
- <18 years old;
- Pregnancy;
- Patient or family member refuse to be enrolled.
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: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of mechanical ventilation
Time Frame: through study completion, an average of 28 days
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through study completion, an average of 28 days
|
ICU length of stay
Time Frame: through study completion, an average of 28 days
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through study completion, an average of 28 days
|
hospital length of stay
Time Frame: through study completion, an average of 28 days
|
through study completion, an average of 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yan Kang, Doctor, West China 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
- Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.
- Seif D, Perera P, Mailhot T, Riley D, Mandavia D. Bedside ultrasound in resuscitation and the rapid ultrasound in shock protocol. Crit Care Res Pract. 2012;2012:503254. doi: 10.1155/2012/503254. Epub 2012 Oct 24.
- Levitov A, Frankel HL, Blaivas M, Kirkpatrick AW, Su E, Evans D, Summerfield DT, Slonim A, Breitkreutz R, Price S, McLaughlin M, Marik PE, Elbarbary M. Guidelines for the Appropriate Use of Bedside General and Cardiac Ultrasonography in the Evaluation of Critically Ill Patients-Part II: Cardiac Ultrasonography. Crit Care Med. 2016 Jun;44(6):1206-27. doi: 10.1097/CCM.0000000000001847.
- Guerin L, Vieillard-Baron A. The Use of Ultrasound in Caring for Patients with Sepsis. Clin Chest Med. 2016 Jun;37(2):299-307. doi: 10.1016/j.ccm.2016.01.005. Epub 2016 Mar 3.
- Wang H, Cui N, Su L, Long Y, Wang X, Zhou X, Chai W, Liu D. Prognostic value of extravascular lung water and its potential role in guiding fluid therapy in septic shock after initial resuscitation. J Crit Care. 2016 Jun;33:106-13. doi: 10.1016/j.jcrc.2016.02.011. Epub 2016 Feb 24.
- Zhou R, Zou T, Yin W, Wang X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Functional mitral regurgitation combined with increased early diastolic transmitral velocity to early mitral annulus diastolic velocity ratio is associated with a poor prognosis in patients with shock. Chin Med J (Engl). 2021 Sep 15;134(19):2299-2305. doi: 10.1097/CM9.0000000000001756.
- Zou T, Yin W, Li Y, Deng L, Zhou R, Wang X, Chao Y, Zhang L, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Hemodynamics in Shock Patients Assessed by Critical Care Ultrasound and Its Relationship to Outcome: A Prospective Study. Biomed Res Int. 2020 Sep 15;2020:5175393. doi: 10.1155/2020/5175393. eCollection 2020.
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
April 5, 2016
Primary Completion (Actual)
June 6, 2017
Study Completion (Actual)
June 6, 2017
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 11, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- West China H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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