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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Jinhua Central Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhongheng Zhang, Jinhua Central Hospital
ClinicalTrials.gov Identifier:
NCT01526382
First received: January 27, 2012
Last updated: February 8, 2013
Last verified: September 2012

January 27, 2012
February 8, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
death from any cause before day 30
28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
patients are followed for 28 days
Complete list of historical versions of study NCT01526382 on ClinicalTrials.gov Archive Site
  • 14 day mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    patients were followed up for 14 days
  • ICU length of stay [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    the time from ICU admission to ICU discharge or death
  • days on mechanical ventilation [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    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.
  • days of vasoactive agents support [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    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
  • ICU free survival days during 30-day period [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    ICU free survival days during 30-day period
  • mechanical ventilation free survival days during 30-day period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    mechanical ventilation free survival days during 30-day period
  • 14 day mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    patients were followed up for 14 days
  • ICU length of stay [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    the time from ICU admission to ICU discharge or death
  • days on mechanical ventilation [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    days during which the patients are on mechnical ventilation
  • days of vasoactive agents support [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    days during which vasoactive agents are used
  • ICU free survival days during 28-day period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    ICU free survival days during 28-day period
  • mechanical ventilation free survival days during 28-day period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    mechanical ventilation free survival days during 28-day period
Not Provided
Not Provided
 
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Septic Shock
  • Acute Respiratory Distress Syndrome
  • Device: PiCCO monitoring (PULSION)
    Patients are monitored with PiCCO system.
    Other Name: PiCCO (pulsion medical system, PULSION PiCCO plus)
  • Procedure: central venous catheter
    patients in this arm can receive central venous catheter
  • Active Comparator: intervention arm
    patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions
    Intervention: Device: PiCCO monitoring (PULSION)
  • 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.
    Intervention: Procedure: central venous catheter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Xiao Xu, MD xwqxx@163.com
China
 
NCT01526382
ZZH-01
Not Provided
Zhongheng Zhang, Jinhua Central Hospital
Jinhua Central Hospital
Not Provided
Study Chair: Zhongheng Zhang, MD Jinhua municipal central hospital
Jinhua Central Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP