ShockNCT03082326
The CCUS Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
An observational study of Shock, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2016to 6 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Shock patients with 6 hours admitted in ICU in west china hospital of sichuan university.
Who may be able to join
- 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.
Who cannot join
- <18 years old;
- Pregnancy;
- Patient or family member refuse to be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock
- Keywords
- shock, critical care ultrasound, hemodynamics, lung pathology, epidemic, prognosis
- Medical subject headings
- Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days
Secondary outcomes (3)
length of mechanical ventilation
Measured: through study completion, an average of 28 days
ICU length of stay
Measured: through study completion, an average of 28 days
hospital length of stay
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start5 Apr 2016
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tongjuan ZOU, West China Hospital
- Investigators
- yan kang, doctor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082326
- Sponsor's protocol ID
- West China H
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 11794169Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.
PubMed 24499231Seif 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.
PubMed 23133747Levitov 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.
PubMed 27182849Guerin 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.
PubMed 27229646Wang 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.
PubMed 27021852Zhou 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.
PubMed 34629416Zou 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.
PubMed 33015171
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Critical Care Ultrasound Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
- ClinicalTrials.gov ID
- NCT03082326
- Acronym / sponsor ID
- West China H
- Conditions
- Shock
- Keywords
- shock, critical care ultrasound, hemodynamics, lung pathology, epidemic, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Apr 2016
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Shock patients with 6 hours admitted in ICU in west china hospital of sichuan university.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- <18 years old;
- Pregnancy;
- Patient or family member refuse to be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: 28 days
3 secondary outcomes
length of mechanical ventilation
Time frame: through study completion, an average of 28 days
ICU length of stay
Time frame: through study completion, an average of 28 days
hospital length of stay
Time frame: through study completion, an average of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Results publication: PubMed 11794169Rivers 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.
- Results publication: PubMed 24499231Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.
- Results publication: PubMed 23133747Seif 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.
- Results publication: PubMed 27182849Levitov 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.
- Results publication: PubMed 27229646Guerin 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.
- Results publication: PubMed 27021852Wang 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.
- Derived from this study: PubMed 34629416Zhou 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.
- Derived from this study: PubMed 33015171Zou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yan kang, doctor study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082326, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.