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

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: PiCCO monitoring (PULSION); Procedure: central venous catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321000
      • department of critical care medicine, Jinhua central hospital
    • Jinhua, Zhejiang, China, 321000
      • Traditional Chinese Medical hospital of Jinhua City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention arm; patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions	Device: PiCCO monitoring (PULSION); Patients are monitored with PiCCO system.; Other Names: PiCCO (pulsion medical system, PULSION PiCCO plus)
Placebo Comparator: control arm; 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; patients in this arm can receive central venous catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jinhua Central Hospital
• Investigators: Study Chair: Zhongheng Zhang, MD, Jinhua municipal central hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: septic shock; mortality; acute respiratory distress syndrome; transpulmonary thermodilution technique
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease; Infant, Newborn, Diseases; Sepsis; Lung Injury; Infant, Premature, Diseases; Syndrome; Shock, Septic; Shock; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ZZH-01