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

Shock Clinical Trial

— PiCCO  

Official title:

Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397188
• Other study ID #: 19741016
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2011
• Last updated: August 20, 2013
• Start date: August 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2013
• Source: Zhejiang University
• Contact: Cui Wei, MD
• Phone: 86 057187783636
• Email: iamcuiwei[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shock

Intervention

Device:
• PiCCO
transpulmonary thermodilution technique

Other:
• sham, no intervention
no intervention

Locations

Country	Name	City	State
China	Second Affiliated Hospital Medical College, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Li danyang

Country where clinical trial is conducted

China, 

Outcome

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