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

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ClinicalTrials.gov Identifier: NCT01397188
Recruitment Status : Unknown
Verified August 2013 by Li danyang, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Li danyang, Zhejiang University

Brief Summary:
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 or disease Intervention/treatment Phase
Shock Device: PiCCO Other: sham, no intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
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
Study Start Date : August 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

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



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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)

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

Responsible Party: Li danyang, Dr, Zhejiang University
ClinicalTrials.gov Identifier: NCT01397188     History of Changes
Other Study ID Numbers: 19741016
First Posted: July 19, 2011    Key Record Dates
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