NCT03082326

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

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

April 5, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2017

Completed
Last Updated

August 1, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 3, 2017

Last Update Submit

July 28, 2017

Conditions

Keywords

shockcritical care ultrasoundhemodynamicslung pathologyepidemicprognosis

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    28 days

Secondary Outcomes (3)

  • length of mechanical ventilation

    through study completion, an average of 28 days

  • ICU length of stay

    through study completion, an average of 28 days

  • hospital length of stay

    through study completion, an average of 28 days

Eligibility Criteria

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

Shock patients with 6 hours admitted in ICU in west china hospital of sichuan university.

You may qualify if:

  • 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.

You may not qualify if:

  • \<18 years old;
  • Pregnancy;
  • Patient or family member refuse to be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital,Sichuan University

Chengde, Sichuan, 610041, China

Location

Related Publications (8)

  • 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.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • yan kang, doctor

    West China Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 17, 2017

Study Start

April 5, 2016

Primary Completion

June 6, 2017

Study Completion

June 6, 2017

Last Updated

August 1, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations