Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit
PiCCO
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 22, 2013
August 1, 2013
2.8 years
July 8, 2011
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mortality at 28 days
mortality at 28 days after diagnosis of shock
28 days
Secondary Outcomes (6)
vasoactive agents-free days
28 days
intensive care unit-free days
28 days
mechanical ventilation-free days
28 days
the change of lactate at 1,3,7 days after the insertion of the Picco catheter
7 days
the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter
7 days
- +1 more secondary outcomes
Study Arms (2)
PiCCO group
EXPERIMENTALIntervention: Device: Picco- thermodilution catheter
sham group
SHAM COMPARATORNo PiCCO Intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- Age \> 85 years
- Pregnancy (positive pregnancy test in women of child bearing age)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li danyanglead
Study Sites (1)
Second Affiliated Hospital Medical College, Zhejiang University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 19, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
August 22, 2013
Record last verified: 2013-08