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Critical Care Ultrasound Oriented Shock Treatment in ICU

Primary Purpose

Shock

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Critical care ultrasound
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring Shock, Critical Care Ultrasound, Lactate, Mortality, Prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

critical care ultrasound

Arm Description

usual care

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

Outcomes

Primary Outcome Measures

28-day mortality
28-day mortality

Secondary Outcome Measures

the length of ICU stay
the length of ICU stay
the total length of hospital stay
the total length of hospital stay
the incidence of AKI
the incidence of AKI

Full Information

First Posted
March 6, 2017
Last Updated
October 30, 2017
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03093987
Brief Title
Critical Care Ultrasound Oriented Shock Treatment in ICU
Official Title
Critical Care Ultrasound Oriented Shock Treatment in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
October 28, 2017 (Actual)
Study Completion Date
October 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
Shock, Critical Care Ultrasound, Lactate, Mortality, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care
Arm Title
critical care ultrasound
Arm Type
Experimental
Arm Description
Circulation management will be adjusted according to the results of critical ultrasound combined with clearance of lactic acid in patients with shock.
Intervention Type
Other
Intervention Name(s)
Critical care ultrasound
Intervention Description
Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock
Primary Outcome Measure Information:
Title
28-day mortality
Description
28-day mortality
Time Frame
through study completion,an average of 28 days
Secondary Outcome Measure Information:
Title
the length of ICU stay
Description
the length of ICU stay
Time Frame
through study completion,an average of 28 days
Title
the total length of hospital stay
Description
the total length of hospital stay
Time Frame
through study completion,an average of 28 days
Title
the incidence of AKI
Description
the incidence of AKI
Time Frame
through study completion,an average of 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22455488
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.
Results Reference
result
PubMed Identifier
23032454
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.
Results Reference
result
PubMed Identifier
23051882
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.
Results Reference
result
PubMed Identifier
18403664
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. Erratum In: Chest. 2013 Aug;144(2):721.
Results Reference
result
PubMed Identifier
22990179
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.
Results Reference
result
PubMed Identifier
24171518
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.
Results Reference
result
PubMed Identifier
26759665
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.
Results Reference
result

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Critical Care Ultrasound Oriented Shock Treatment in ICU

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