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

This study is currently recruiting participants.
Verified August 2013 by Zhejiang University
Sponsor:
Information provided by (Responsible Party):
Li danyang, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01397188
First received: July 8, 2011
Last updated: August 20, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Zhejiang University:

Primary Outcome Measures:
  • mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    mortality at 28 days after diagnosis of shock


Secondary Outcome Measures:
  • vasoactive agents-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Li danyang, Dr, Zhejiang University
ClinicalTrials.gov Identifier: NCT01397188     History of Changes
Other Study ID Numbers: 19741016
Study First Received: July 8, 2011
Last Updated: August 20, 2013
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
PiCCO

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014