Critical Care Ultrasound Oriented Shock Treatment in ICU

Shock Clinical Trial

Official title:

Critical Care Ultrasound Oriented Shock Treatment in ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093987
• Other study ID #: West China Hos
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: October 30, 2017
• Start date: April 5, 2017
• Est. completion date: October 28, 2017

Study information

• Verified date: October 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 28, 2017
• Est. primary completion date: October 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shock

Intervention

Other:
• Critical care ultrasound
Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. Review. — View 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. Review. — View Citation

Lichtenstein DA, Mezière 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. Erratum in: Chest. 2013 Aug;144(2):721. — View Citation

Manno E, Navarra M, Faccio L, Motevallian M, Bertolaccini L, Mfochivè 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. — View 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. Review. — View Citation

Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	28-day mortality	through study completion,an average of 28 days
Secondary	the length of ICU stay	the length of ICU stay	through study completion,an average of 28 days
Secondary	the total length of hospital stay	the total length of hospital stay	through study completion,an average of 28 days
Secondary	the incidence of AKI	the incidence of AKI	through study completion,an average of 28 days