Critical Care Ultrasound Oriented Shock Treatment in ICU

NCT03093987 | Completed DMC

• 1 other identifier: West China Hos
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Keywords

Shock; Critical Care Ultrasound; Lactate; Mortality; Prognosis

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  28-day mortality

  through study completion,an average of 28 days

Secondary Outcomes (3)

• the length of ICU stay

  through study completion,an average of 28 days

• the total length of hospital stay

  through study completion,an average of 28 days

• the incidence of AKI

  through study completion,an average of 28 days

Study Arms (2)

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.

Other: Critical care ultrasound

Interventions

Critical care ultrasound OTHER

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

critical care ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (7)

• 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.

  PMID: 22455488 RESULT

• 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.

  PMID: 23032454 RESULT

• 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.

  PMID: 23051882 RESULT

• 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.

  PMID: 18403664 RESULT

• 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.

  PMID: 22990179 RESULT

• 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.

  PMID: 24171518 RESULT

• 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.

  PMID: 26759665 RESULT

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 28, 2017
• Study Start: April 5, 2017
• Primary Completion: October 28, 2017
• Study Completion: October 28, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)