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

Jinhua Central Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Respiratory Distress Syndrome; Septic Shock

Treatments: Device: PiCCO monitoring (PULSION); Procedure: central venous catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01526382

ZZH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups, including a placebo group

intervention arm

Active Comparator group

Description:

patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions

Treatment:

Device: PiCCO monitoring (PULSION)

control arm

Placebo Comparator group

Description:

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.

Treatment:

Procedure: central venous catheter