Critical Care Ultrasound Oriented Shock Treatment in ICU

NCT ID: NCT03093987

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2017-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Shock

Keywords

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Shock Critical Care Ultrasound Lactate Mortality Prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Critical care ultrasound

Intervention Type OTHER

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

Interventions

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Critical care ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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tongjuan ZOU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22455488 (View on PubMed)

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.

Reference Type RESULT
PMID: 23032454 (View on PubMed)

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.

Reference Type RESULT
PMID: 23051882 (View on PubMed)

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.

Reference Type RESULT
PMID: 18403664 (View on PubMed)

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.

Reference Type RESULT
PMID: 22990179 (View on PubMed)

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.

Reference Type RESULT
PMID: 24171518 (View on PubMed)

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.

Reference Type RESULT
PMID: 26759665 (View on PubMed)

Other Identifiers

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West China Hos

Identifier Type: -

Identifier Source: org_study_id