Septic ShockNCT01920776
Focused Ultrasound in Septic Shock Patients
A study testing ultrasound examination and Ultrasound group in people with Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- ultrasound examination and Ultrasound group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jul 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18yr
- survive more than 24hrs
- fulfilled septic shock
Who cannot join
- age < 18yr
- pregnant
- DNR
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital ICU
Beijing, 100730
Xiaoting Wang, Doctor, 86-10-69152300, ozohom@yahoo.com
About this study
The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. The routine treatment group will receive routine treatment according to the SSC guideline. The study group will receive additional ultrasound examination, which will decide the improvement of therapy. Therapy change based on ultrasound results and the prognosis will be recorded.
- Conditions
- Septic Shock
- Being tested
- ultrasound examination, Ultrasound group
- Keywords
- critical ultrasound
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationOther
Ultrasound groupOther
Ultrasound group will receive ultrasound examination at least once a day, the results will be noted to the attending who is in charge of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Rutine treatment group, Ultrasound group | Experimental | Not described Receives: Other: ultrasound examination; Other: Ultrasound group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 28day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIiaoting Wang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920776
- Sponsor's protocol ID
- LHMBCSDXJS-SEPTIC SHOCK
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
Publications
Du W, Wang XT, Long Y, Liu DW. Efficacy and Safety of Esmolol in Treatment of Patients with Septic Shock. Chin Med J (Engl). 2016 Jul 20;129(14):1658-65. doi: 10.4103/0366-6999.185856.
PubMed 27411452
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT01920776
- Acronym / sponsor ID
- LHMBCSDXJS-SEPTIC SHOCK
- Conditions
- Septic Shock
- Keywords
- critical ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- 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.
The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. The routine treatment group will receive routine treatment according to the SSC guideline. The study group will receive additional ultrasound examination, which will decide the improvement of therapy. Therapy change based on ultrasound results and the prognosis will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rutine treatment group, Ultrasound group | Experimental | Other: ultrasound examination, Other: Ultrasound group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age>18yr
- survive more than 24hrs
- fulfilled septic shock
Key exclusion criteria (3 listed)
- age < 18yr
- pregnant
- DNR
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 |
|---|---|---|
| ultrasound examination | Other | Rutine treatment group, Ultrasound group |
| Ultrasound groupUltrasound group will receive ultrasound examination at least once a day, the results will be noted to the attending who is in charge of the treatment. | Other | Rutine treatment group, Ultrasound group |
Primary outcome
mortality
Time frame: 28day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 27411452Du W, Wang XT, Long Y, Liu DW. Efficacy and Safety of Esmolol in Treatment of Patients with Septic Shock. Chin Med J (Engl). 2016 Jul 20;129(14):1658-65. doi: 10.4103/0366-6999.185856.
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Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound examination and Ultrasound group in people with Septic Shock, run by Peking Union Medical College 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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28day). 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 NCT01920776, which also lists 1 linked publication.
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 12 Aug 2013.