ShockNCT03093987
Critical Care Ultrasound Oriented Shock Treatment in ICU
A study testing Critical care ultrasound in people with Shock, run by West China Hospital at 1 site in China.
Trial summary
Objective To investigate whether critical care ultrasound oriented shock management in shock patients in intensive care unit(ICU) can improve outcome. Methods Randomized controlled research. Patients were randomly allocated to two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Critical care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to 28 Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- SBP <90 mm Hg or MAP <65 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
Objective
To investigate whether critical care ultrasound oriented shock management in shock patients in intensive care unit(ICU) can improve outcome.
Read more
Methods
Randomized controlled research. Patients were randomly allocated to two groups. In the critical care ultrasound oriented shock management group (CUSS group), treatment was oriented by the findings of critical care ultrasound in each shock phase, while in the control group the decisions about the monitoring and management were made by the clinical team. The goal of treatments in both groups were decreasing lactate by 20% or more per 2 hours for the Optimization phase in shock management, and no increase lactate level when removing the fluid in de-escalation phase. The primary outcome measure were hospital mortality and 28-day mortality, the secondary outcome measure were the length of ventilation and the length of ICU stay.
- Conditions
- Shock
- Being tested
- Critical care ultrasound
- Keywords
- Shock, Critical Care Ultrasound, Lactate, Mortality, Prognosis
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical care ultrasoundOther
Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | usual care |
| critical care ultrasound | Experimental | Circulation management will be adjusted according to the results of critical ultrasound combined with clearance of lactic acid in patients with shock. Receives: Other: Critical care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day mortality
Measured: through study completion,an average of 28 days
Secondary outcomes (3)
the length of ICU stay
the length of ICU stay
Measured: through study completion,an average of 28 days
the total length of hospital stay
the total length of hospital stay
Measured: through study completion,an average of 28 days
the incidence of AKI
the incidence of AKI
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 posted28 Mar 2017
- Study start5 Apr 2017
- Primary completion28 Oct 2017
- Study completion28 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093987
- Sponsor's protocol ID
- West China Hos
- Status last verified
- Oct 2017
- First submitted
- 6 Mar 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lichtenstein D. Fluid administration limited by lung sonography: the place of lung ultrasound in assessment of acute circulatory failure (the FALLS-protocol). Expert Rev Respir Med. 2012 Apr;6(2):155-62. doi: 10.1586/ers.12.13.
PubMed 22455488Schmidt GA, Koenig S, Mayo PH. Shock: ultrasound to guide diagnosis and therapy. Chest. 2012 Oct;142(4):1042-1048. doi: 10.1378/chest.12-1297.
PubMed 23032454Holm JH, Frederiksen CA, Juhl-Olsen P, Sloth E. Perioperative use of focus assessed transthoracic echocardiography (FATE). Anesth Analg. 2012 Nov;115(5):1029-32. doi: 10.1213/ANE.0b013e31826dd867. Epub 2012 Oct 9. No abstract available.
PubMed 23051882Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
PubMed 18403664Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochive A, Pesce M, Evangelista A. Deep impact of ultrasound in the intensive care unit: the "ICU-sound" protocol. Anesthesiology. 2012 Oct;117(4):801-9. doi: 10.1097/ALN.0b013e318264c621.
PubMed 22990179Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
PubMed 24171518Bhat SR, Swenson KE, Francis MW, Wira CR. Lactate Clearance Predicts Survival Among Patients in the Emergency Department with Severe Sepsis. West J Emerg Med. 2015 Dec;16(7):1118-26. doi: 10.5811/westjem.2015.10.27577. Epub 2015 Dec 8.
PubMed 26759665
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Care Ultrasound Oriented Shock Treatment in ICU
- ClinicalTrials.gov ID
- NCT03093987
- Acronym / sponsor ID
- West China Hos
- Conditions
- Shock
- Keywords
- Shock, Critical Care Ultrasound, Lactate, Mortality, Prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 28 Oct 2017 (actual)
- Study completion
- 28 Oct 2017 (actual)
- First posted
- 28 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.
Objective
To investigate whether critical care ultrasound oriented shock management in shock patients in intensive care unit(ICU) can improve outcome.
Methods
Randomized controlled research. Patients were randomly allocated to two groups. In the critical care ultrasound oriented shock management group (CUSS group), treatment was oriented by the findings of critical care ultrasound in each shock phase, while in the control group the decisions about the monitoring and management were made by the clinical team. The goal of treatments in both groups were decreasing lactate by 20% or more per 2 hours for the Optimization phase in shock management, and no increase lactate level when removing the fluid in de-escalation phase. The primary outcome measure were hospital mortality and 28-day mortality, the secondary outcome measure were the length of ventilation and the length of ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –usual care |
| critical care ultrasound | Experimental | Other: Critical care ultrasoundCirculation management will be adjusted according to the results of critical ultrasound combined with clearance of lactic acid in patients with shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SBP <90 mm Hg or MAP <65 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical care ultrasoundCirculateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock | Other | critical care ultrasound |
Primary outcome
28-day mortality
Time frame: through study completion,an average of 28 days
28-day mortality
3 secondary outcomes
the length of ICU stay
Time frame: through study completion,an average of 28 days
the total length of hospital stay
Time frame: through study completion,an average of 28 days
the incidence of AKI
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 Nov 2017.
- Results publication: PubMed 22455488Lichtenstein D. Fluid administration limited by lung sonography: the place of lung ultrasound in assessment of acute circulatory failure (the FALLS-protocol). Expert Rev Respir Med. 2012 Apr;6(2):155-62. doi: 10.1586/ers.12.13.
- Results publication: PubMed 23032454Schmidt GA, Koenig S, Mayo PH. Shock: ultrasound to guide diagnosis and therapy. Chest. 2012 Oct;142(4):1042-1048. doi: 10.1378/chest.12-1297.
- Results publication: PubMed 23051882Holm JH, Frederiksen CA, Juhl-Olsen P, Sloth E. Perioperative use of focus assessed transthoracic echocardiography (FATE). Anesth Analg. 2012 Nov;115(5):1029-32. doi: 10.1213/ANE.0b013e31826dd867. Epub 2012 Oct 9. No abstract available.
- Results publication: PubMed 18403664Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
- Results publication: PubMed 22990179Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochive A, Pesce M, Evangelista A. Deep impact of ultrasound in the intensive care unit: the "ICU-sound" protocol. Anesthesiology. 2012 Oct;117(4):801-9. doi: 10.1097/ALN.0b013e318264c621.
- Results publication: PubMed 24171518Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
- Results publication: PubMed 26759665Bhat SR, Swenson KE, Francis MW, Wira CR. Lactate Clearance Predicts Survival Among Patients in the Emergency Department with Severe Sepsis. West J Emerg Med. 2015 Dec;16(7):1118-26. doi: 10.5811/westjem.2015.10.27577. Epub 2015 Dec 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical care ultrasound in people with 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 Nov 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?
28-day mortality (time frame: through study completion,an average of 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 NCT03093987, which also lists 7 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 Nov 2017.