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Critical Care Ultrasound Oriented Shock Treatment in ICU

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by West China Hospital
Sponsor:
Information provided by (Responsible Party):
tongjuan ZOU, West China Hospital
ClinicalTrials.gov Identifier:
NCT03093987
First received: March 6, 2017
Last updated: March 22, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Shock
Other: Critical care ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Critical Care Ultrasound Oriented Shock Treatment in ICU

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: through study completion,an average of 28 days ]
    28-day mortality


Secondary Outcome Measures:
  • the length of ICU stay [ Time Frame: through study completion,an average of 28 days ]
    the length of ICU stay

  • the total length of hospital stay [ Time Frame: through study completion,an average of 28 days ]
    the total length of hospital stay

  • the incidence of AKI [ Time Frame: through study completion,an average of 28 days ]
    the incidence of AKI


Estimated Enrollment: 180
Anticipated Study Start Date: March 27, 2017
Estimated Study Completion Date: October 30, 2017
Estimated Primary Completion Date: October 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03093987

Locations
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Yao Qin, Doctor    (+86)13488944952    1005058104@qq.com   
Sponsors and Collaborators
West China Hospital
  More Information

Publications:
Responsible Party: tongjuan ZOU, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03093987     History of Changes
Other Study ID Numbers: West China Hos
Study First Received: March 6, 2017
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by West China Hospital:
Shock
Critical Care Ultrasound
Lactate
Mortality
Prognosis

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on March 28, 2017