Clinical trial NCT03093987: Critical Care Ultrasound Oriented Shock Treatment in ICU
Official title: Critical Care Ultrasound Oriented Shock Treatment in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock
Keywords: Shock
Critical Care Ultrasound
Lactate
Mortality
Prognosis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: 28-day mortality
timeFrame: through study completion,an average of 28 days
Secondary outcomes:
measure: the length of ICU stay
timeFrame: through study completion,an average of 28 days
measure: the total length of hospital stay
timeFrame: through study completion,an average of 28 days
measure: the incidence of AKI
timeFrame: through study completion,an average of 28 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.