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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Jinhua Central Hospital
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
  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


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526382

Contacts
Contact: Xiao Xu, MD xwqxx@163.com

Locations
China, Zhejiang
department of critical care medicine, Jinhua central hospital Recruiting
Jinhua, Zhejiang, China, 321000
Contact: Zhongheng Zhang, MD       zh_zhang1984@hotmail.com   
Principal Investigator: Zhongheng Zhang, MD         
Principal Investigator: Xiao Xu, MD         
Principal Investigator: Hongying Ni, MD         
Principal Investigator: Hongyang Zhu, MD         
Sub-Investigator: Xiaoyan Sheng, MD         
Sub-Investigator: Ni Jin, MD         
Sub-Investigator: Li Zhu, MD         
Sub-Investigator: Hongsheng Deng, MB         
Traditional Chinese Medical hospital of Jinhua City Recruiting
Jinhua, Zhejiang, China, 321000
Contact: Huilan Chen, M.M.       jhliliangjun@sohu.com   
Sub-Investigator: Zhangquan Cao, M.B.         
Principal Investigator: Huilan Chen, M.M.         
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: February 8, 2013
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:
Shock, Septic
Critical Illness
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Shock
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 21, 2014