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Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit (PiCCO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Li danyang, Zhejiang University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397188
First Posted: July 19, 2011
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Li danyang, Zhejiang University
  Purpose
PiCCO has become a widely used haemodynamic monitoring device in the management of shock patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP in shock patients has not been determined. Patients will be randomly assigned to a Picco group or the control group, hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP will be observed. The conclusion will supply evidence for the clinical effectiveness of Picco in shock patients.

Condition Intervention
Shock Device: PiCCO Other: sham, no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU

Resource links provided by NLM:


Further study details as provided by Li danyang, Zhejiang University:

Primary Outcome Measures:
  • mortality at 28 days [ Time Frame: 28 days ]
    mortality at 28 days after diagnosis of shock


Secondary Outcome Measures:
  • vasoactive agents-free days [ Time Frame: 28 days ]
    vasoactive agents-free days: the number of days from day 1 to day 28 without use of vasoactive agents.

  • intensive care unit-free days [ Time Frame: 28 days ]
    intensive care unit(ICU) free days, defined as the number of days from day 1 to day 28 without ICU stay.

  • mechanical ventilation-free days [ Time Frame: 28 days ]
    ventilator free days: the number of days from day 1 to day 28 during which the patient breathed spontaneously

  • the change of lactate at 1,3,7 days after the insertion of the Picco catheter [ Time Frame: 7 days ]
    blood samples will be taken before the insertion of the Picco catheter and everyday after the insertion, the change of lactate at 1,3,7 days after the insertion of the Picco catheter will be collected.

  • the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter [ Time Frame: 7 days ]
    blood samples will be taken before the insertion of the Picco catheter and everyday after the insertion, the change of BNP at 1,3,7 days after the insertion of the Picco catheter will be collected.

  • mortality at 90 days [ Time Frame: 90 days ]
    mortality at 90 days after diagnosis of shock


Estimated Enrollment: 320
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PiCCO group
Intervention: Device: Picco- thermodilution catheter
Device: PiCCO
transpulmonary thermodilution technique
Sham Comparator: sham group
No PiCCO Intervention
Other: sham, no intervention
no intervention

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • critically ill patients with shock: Mean arterial pressure (MAP) < 65 mmHg (< 8,7 kPa) or systolic arterial pressure (SAP) < 90 mmHg (< 12 kPa) or the need for vasopressor (Norepinephrine <0.05µg/kg/min) to support the MAP ≥ 65 mmHg (≥ 8,7 kPa) or the SAP ≥ 90 mmHg ≥ 12 kPa), when one of these criteria has lasted for 4 hours or longer

Exclusion Criteria:

  • Age < 18 years
  • Age > 85 years
  • Pregnancy (positive pregnancy test in women of child bearing age)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397188


Contacts
Contact: Cui Wei, MD 86 057187783636 iamcuiwei@gmail.com
Contact: Li Danyang, MD 86 13588001291 elidanyang@gmail.com

Locations
China, Zhejiang
Second Affiliated Hospital Medical College, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Cui Wei, MD    +86 0571 87783636    iamcuiwei@gmail.com   
Contact: Li Danyang, MD    +86 13588001291    elidanyang@gmail.com   
Sponsors and Collaborators
Li danyang
  More Information

Responsible Party: Li danyang, Dr, Zhejiang University
ClinicalTrials.gov Identifier: NCT01397188     History of Changes
Other Study ID Numbers: 19741016
First Submitted: July 8, 2011
First Posted: July 19, 2011
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Li danyang, Zhejiang University:
PiCCO

Additional relevant MeSH terms:
Shock
Pathologic Processes