Shock Clinical Trial
— PiCCOOfficial title:
Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | August 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital Medical College, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Li danyang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mortality at 28 days | mortality at 28 days after diagnosis of shock | 28 days | No |
Secondary | vasoactive agents-free days | vasoactive agents-free days: the number of days from day 1 to day 28 without use of vasoactive agents. | 28 days | No |
Secondary | intensive care unit-free days | intensive care unit(ICU) free days, defined as the number of days from day 1 to day 28 without ICU stay. | 28 days | No |
Secondary | mechanical ventilation-free days | ventilator free days: the number of days from day 1 to day 28 during which the patient breathed spontaneously | 28 days | No |
Secondary | the change of lactate at 1,3,7 days after the insertion of the Picco catheter | 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. | 7 days | No |
Secondary | the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter | 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. | 7 days | No |
Secondary | mortality at 90 days | mortality at 90 days after diagnosis of shock | 90 days | No |
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