Clinical trial NCT01526382: Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome
Official title: Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Septic Shock
Acute Respiratory Distress Syndrome
Keywords: septic shock
acute respiratory distress syndrome
transpulmonary thermodilution technique
mortality
Lead sponsor: Jinhua Central Hospital
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Detailed description: PiCCO comprises techniques of pulse contour analysis and transpulmonary thermodilution, and can provide important information on hemodynamics and pulmonary functions. It has been widely used in critical care settings for several decades. Together with pulmonary artery catheter (PAC), it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. During last two decades, many well designed clinical trials have been conducted to see whether the use of PAC would benefit patient outcome. The result consistently showed that PAC added no benefit in terms of mortality, ICU length of stay, organ failure free survival days, and the length of mechanical ventilation. Since PiCCO is relatively new to PAC, and its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Eligibility criteria: Inclusion Criteria:

Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.

Shock was defined by the presence 4 criteria:

* Heart rate of at least 90/min;
* A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation;
* The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine;
* at least 1 of 3 signs of hypoperfusion (urine output \< 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value).

Acute respiratory distress syndrome：

* the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower,
* bilateral pulmonary infiltrates or a chest radiograph consistent with edema;
* no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation.

Exclusion Criteria:

* Patients were moribund.
* signed do-not-resuscitation odor.

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
Secondary outcomes:
measure: 14 day mortality
timeFrame: 14 days
measure: ICU length of stay
timeFrame: up to 30 days
measure: days on mechanical ventilation
timeFrame: up to 30 days
measure: days of vasoactive agents support
timeFrame: up to 30 days
measure: ICU free survival days during 30-day period
timeFrame: 30 days
measure: mechanical ventilation free survival days during 30-day period
timeFrame: 28 days
Other outcomes:
Locations:
city: Jinhua
country: China
facility: department of critical care medicine, Jinhua central hospital
state: Zhejiang
city: Jinhua
country: China
facility: Traditional Chinese Medical hospital of Jinhua City
state: Zhejiang
Study officials:
affiliation: Jinhua Municipal Central Hospital
name: Zhongheng Zhang, MD
role: STUDY_CHAIR
References:
citation: Richard C, Warszawski J, Anguel N, Deye N, Combes A, Barnoud D, Boulain T, Lefort Y, Fartoukh M, Baud F, Boyer A, Brochard L, Teboul JL; French Pulmonary Artery Catheter Study Group. Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2713-20. doi: 10.1001/jama.290.20.2713.
citation: Zhang Z, Xu X, Yao M, Chen H, Ni H, Fan H. 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. Trials. 2013 Feb 1;14:32. doi: 10.1186/1745-6215-14-32.