Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome

Jinhua Central Hospital350 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

350

Conditions

Septic Shock Acute Respiratory Distress Syndrome

Interventions

PiCCO monitoring (PULSION)DEVICE

Patients are monitored with PiCCO system.

central venous catheterPROCEDURE

patients in this arm can receive central venous catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

department of critical care medicine, Jinhua central hospital

Jinhua, Zhejiang, China

Traditional Chinese Medical hospital of Jinhua City

Jinhua, Zhejiang, China

Outcomes

Primary Outcomes

30 day mortality

death from any cause before day 30

Time frame: 30 days

Secondary Outcomes

14 day mortality

patients were followed up for 14 days

Time frame: 14 days

ICU length of stay

the time from ICU admission to ICU discharge or death

Time frame: up to 30 days

days on mechanical ventilation

days during which the patients are on mechnical ventilation: The criteria for termination of mechanical ventilation: a cooperative patient, recovery from primary disease, hemodynamically stable, adequate and strong cough reflex, positive end-expiratory pressure \<5 cmH2O, pressure support \<10 cmH2O and the spontaneous breathing trial is successfully passed.

Time frame: up to 30 days

days of vasoactive agents support

days during which vasoactive agents are used: The sum of the number of days with one or more vasoactive agents to maintain a mean arterial pressure \>60 mmHg

Time frame: up to 30 days

ICU free survival days during 30-day period

Time frame: 30 days

mechanical ventilation free survival days during 30-day period

Time frame: 28 days

Data from ClinicalTrials.gov

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