ClinicalTrials.gg
CompletedNCT03093987Updated Nov 1, 2017

Critical Care Ultrasound Oriented Shock Treatment in ICU

An interventional study of Critical care ultrasound in Shock, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Shock

Browse trials for

Keywords

  • Shock
  • Critical Care Ultrasound
  • Lactate
  • Mortality
  • Prognosis
03

In context

Shock

921 studies on the registry are indexed under Shock; 172 are open to participants now.

This study's enrollment of 150 is above the median of 76 across 537 interventional studies indexed under Shock.

Browse Shock studies →

Lead sponsor

West China Hospital is the lead sponsor of 498 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • \<18 years old;
  • Pregnancy;
  • Patient or family member refuse to be enrolled.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (actual)

Study arms

  • No intervention
    control group

    usual care

  • Experimental
    critical care ultrasound

    Circulation management will be adjusted according to the results of critical ultrasound combined with clearance of lactic acid in patients with shock.

    Other: Critical care ultrasound

Interventions

  • OtherCritical care ultrasound

    Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock

06

What researchers measure

Primary outcomes

  1. 28-day mortality

    28-day mortality

    Time frame: through study completion,an average of 28 days

Secondary outcomes

  1. the length of ICU stay

    the length of ICU stay

    Time frame: through study completion,an average of 28 days

  2. the total length of hospital stay

    the total length of hospital stay

    Time frame: through study completion,an average of 28 days

  3. the incidence of AKI

    the incidence of AKI

    Time frame: through study completion,an average of 28 days

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
08

References and documents

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 22455488 ↗
  • Schmidt 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 23032454 ↗
  • Holm 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 23051882 ↗
  • Lichtenstein 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 18403664 ↗
  • Manno 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 22990179 ↗
  • Vincent 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 24171518 ↗
  • Bhat 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03093987
Responsible party
tongjuan ZOU (Professor, West China Hospital) — Principal investigator
First posted
Mar 28, 2017
Start date
Apr 5, 2017
Primary completion
Oct 28, 2017
Completion
Oct 28, 2017
Last update
Nov 1, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion