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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhongheng Zhang, Jinhua Central Hospital
ClinicalTrials.gov Identifier:
NCT01526382
First received: January 27, 2012
Last updated: April 30, 2015
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Septic Shock
Acute Respiratory Distress Syndrome
Device: PiCCO monitoring (PULSION)
Procedure: central venous catheter
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory

Resource links provided by NLM:


Further study details as provided by Jinhua Central Hospital:

Primary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    death from any cause before day 30


Secondary Outcome Measures:
  • 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


Enrollment: 350
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01526382

Locations
China, Zhejiang
department of critical care medicine, Jinhua central hospital
Jinhua, Zhejiang, China, 321000
Traditional Chinese Medical hospital of Jinhua City
Jinhua, Zhejiang, China, 321000
Sponsors and Collaborators
Jinhua Central Hospital
Investigators
Study Chair: Zhongheng Zhang, MD Jinhua municipal central hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhongheng Zhang, principal investigator, Jinhua Central Hospital
ClinicalTrials.gov Identifier: NCT01526382     History of Changes
Other Study ID Numbers: ZZH-01
Study First Received: January 27, 2012
Last Updated: April 30, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Jinhua Central Hospital:
septic shock
acute respiratory distress syndrome
transpulmonary thermodilution technique
mortality

Additional relevant MeSH terms:
Acute Lung Injury
Critical Illness
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Shock
Shock, Septic
Disease Attributes
Infant, Newborn, Diseases
Infant, Premature, Diseases
Infection
Inflammation
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on September 01, 2015