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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory

Conditions
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Septic Shock, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: PiCCO monitoring (PULSION)
* Procedure: central venous catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention arm<br>patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions | Device: PiCCO monitoring (PULSION)<br>* Patients are monitored with PiCCO system.<br>* Other names: PiCCO (pulsion medical system, PULSION PiCCO plus);|
| Placebo Comparator: control arm<br>Patients in this arm do not receive PiCCO monitoring device to guide fluid management, but central venous catheter can be inserted at the discretion of treating physician. | Procedure: central venous catheter<br>* patients in this arm can receive central venous catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality | death from any cause before day 30 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14 day mortality | patients were followed up for 14 days | 14 days | 
| ICU length of stay | the time from ICU admission to ICU discharge or death | 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. | 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 | up to 30 days | 
| ICU free survival days during 30-day period | ICU free survival days during 30-day period | 30 days | 
| mechanical ventilation free survival days during 30-day period | mechanical ventilation free survival days during 30-day period | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, acute respiratory distress syndrome, transpulmonary thermodilution technique, mortality