The CCUS Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value

Shock Clinical Trial

Official title:

The Critical Care Ultrasound Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082326
• Other study ID #: West China H
• Status: Completed
• Phase: N/A
• First received: March 3, 2017
• Last updated: July 28, 2017
• Start date: April 5, 2016
• Est. completion date: June 6, 2017

Study information

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

Clinical Trial Summary

Shock is a common condition in critical care unit (ICU). It is extremely important that the patient accepts early goal-directed therapy (EGDT) treatment in the early stage of shock. However, several studies failed to demonstrate that the well used variables such as CVP and others could direct to a better treatment. In recent years, critical care ultrasound (CCUS) has been respected as a reliable noninvasive tool and widely used in ICU practice. With CCUS the investigators can accurately acquired the detailed information of the characteristic of the hemodynamics and lung pathology (the systole and diastole function, volume status, valve insufficiency, lung, edema, consolidation, and pleural effusion, etc.). To the investigators knowledge, there is no study investigating the epidemic of such ultrasonic variables and its value to predict to outcome. The aim of this study is to investigate the epidemic and the prognostic value of CCUS Based Characteristic of Hemodynamic and Lung pathology in Early Stage of Shock in patients admitted in ICU.

Description:

Adult patients who admitted to the intensive care unit of West China hospital of sichuan university with shock from April 2016 to April 2017 enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. SBP<90 mm Hg or MAP <70 mm Hg or SBP decrease >40mmHg or need vasoactive drugs;

2. Skin that is cold and clammy, capillary refill time >4.5s, urine output of <0.5ml/Kg.hr and lactate>2mmol/L;

3. SHOCK presented within 6 hr.

Exclusion Criteria:

1. <18 years old;

2. Pregnancy;

3. Patient or family member refuse to be enrolled.

Related Conditions & MeSH terms

• Shock

Locations

Country	Name	City	State
China	West China Hospital,Sichuan University	Chengde	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Guérin L, Vieillard-Baron A. The Use of Ultrasound in Caring for Patients with Sepsis. Clin Chest Med. 2016 Jun;37(2):299-307. doi: 10.1016/j.ccm.2016.01.005. Epub 2016 Mar 3. Review. — View Citation

Levitov A, Frankel HL, Blaivas M, Kirkpatrick AW, Su E, Evans D, Summerfield DT, Slonim A, Breitkreutz R, Price S, McLaughlin M, Marik PE, Elbarbary M. Guidelines for the Appropriate Use of Bedside General and Cardiac Ultrasonography in the Evaluation of — View Citation

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):13 — View Citation

Seif D, Perera P, Mailhot T, Riley D, Mandavia D. Bedside ultrasound in resuscitation and the rapid ultrasound in shock protocol. Crit Care Res Pract. 2012;2012:503254. doi: 10.1155/2012/503254. Epub 2012 Oct 24. — View Citation

Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. — View Citation

Wang H, Cui N, Su L, Long Y, Wang X, Zhou X, Chai W, Liu D. Prognostic value of extravascular lung water and its potential role in guiding fluid therapy in septic shock after initial resuscitation. J Crit Care. 2016 Jun;33:106-13. doi: 10.1016/j.jcrc.2016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		28 days
Secondary	length of mechanical ventilation		through study completion, an average of 28 days
Secondary	ICU length of stay		through study completion, an average of 28 days
Secondary	hospital length of stay		through study completion, an average of 28 days