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

Primary Purpose

Septic Shock, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PiCCO monitoring (PULSION)
central venous catheter
Sponsored by
Jinhua Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, acute respiratory distress syndrome, transpulmonary thermodilution technique, mortality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention arm

control arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

30 day mortality
death from any cause before day 30

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2012
Last Updated
April 30, 2015
Sponsor
Jinhua Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01526382
Brief Title
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome
Acronym
PiCCO
Official Title
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinhua Central Hospital

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Respiratory Distress Syndrome
Keywords
septic shock, acute respiratory distress syndrome, transpulmonary thermodilution technique, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Active Comparator
Arm Description
patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions
Arm Title
control arm
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
PiCCO monitoring (PULSION)
Other Intervention Name(s)
PiCCO (pulsion medical system, PULSION PiCCO plus)
Intervention Description
Patients are monitored with PiCCO system.
Intervention Type
Procedure
Intervention Name(s)
central venous catheter
Intervention Description
patients in this arm can receive central venous catheter
Primary Outcome Measure Information:
Title
30 day mortality
Description
death from any cause before day 30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
14 day mortality
Description
patients were followed up for 14 days
Time Frame
14 days
Title
ICU length of stay
Description
the time from ICU admission to ICU discharge or death
Time Frame
up to 30 days
Title
days on mechanical ventilation
Description
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
Title
days of vasoactive agents support
Description
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
Title
ICU free survival days during 30-day period
Description
ICU free survival days during 30-day period
Time Frame
30 days
Title
mechanical ventilation free survival days during 30-day period
Description
mechanical ventilation free survival days during 30-day period
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongheng Zhang, MD
Organizational Affiliation
Jinhua Municipal Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
department of critical care medicine, Jinhua central hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Facility Name
Traditional Chinese Medical hospital of Jinhua City
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
14645314
Citation
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.
Results Reference
background
PubMed Identifier
23374652
Citation
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.
Results Reference
derived

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

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