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Open Access Highly Accessed Study protocol

Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial

Zhongheng Zhang1*, Xiao Xu1, Min Yao2, Huilan Chen3, Hongying Ni1 and Haozhe Fan1

Author Affiliations

1 Department of Critical Care Medicine, Jinhua Municipal Central Hospital, 351 Mingyue Street, Jinhua City, Zhejiang, 3210002, PR China

2 Department of Surgery, Limb Preservation and Wound Care Research, Boston Medical Center and Boston University School of Medicine, Boston, MA, 02118, USA

3 Department of Critical Care Medicine, Traditional Chinese Medical Hospital of Jinhua City, Jinhua City, Zhejiang, PR China

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Trials 2013, 14:32  doi:10.1186/1745-6215-14-32

Published: 1 February 2013

Abstract

Background

Hemodynamic monitoring is very important in critically ill patients with shock or acute respiratory distress syndrome(ARDS). The PiCCO (Pulse index Contour Continuous Cardiac Output, Pulsion Medical Systems, Germany) system has been developed and used in critical care settings for several years. However, its impact on clinical outcomes remains unknown.

Methods/design

The study is a randomized controlled multi-center trial. A total of 708 patients with ARDS, septic shock or both will be included from January 2012 to January 2014. Subjects will be randomized to receive PiCCO monitoring or not. Our primary end point is 30-day mortality, and secondary outcome measures include ICU length of stay, days on mechanical ventilation, days of vasoactive agent support, ICU-free survival days during a 30-day period, mechanical-ventilation-free survival days during a 30-day period, and maximum SOFA score during the first 7 days.

Discussion

We investigate whether the use of PiCCO monitoring will improve patient outcomes in critically ill patients with ARDS or septic shock. This will provide additional data on hemodynamic monitoring and help clinicians to make decisions on the use of PiCCO.

Trial registration

http://www.clinicaltrials.gov webcite NCT01526382

Keywords:
Pulse index Contour Continuous Cardiac Output; Shock; Acute respiratory distress syndrome; Mortality