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

Not Applicable

• Conditions: Shock
• Interventions: Device: PiCCO; Other: sham, no intervention

• Registration Number: NCT01397188
• Lead Sponsor: Li danyang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2011-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-22
• Primary Completion: 2014-06
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PiCCO group	PiCCO	Intervention: Device: Picco- thermodilution catheter
sham group	sham, no intervention	No PiCCO Intervention

Primary Outcome Measures

Name	Time	Method
mortality at 28 days	28 days	mortality at 28 days after diagnosis of shock

Secondary Outcome Measures

Name	Time	Method
vasoactive agents-free days	28 days	vasoactive agents-free days: the number of days from day 1 to day 28 without use of vasoactive agents.
intensive care unit-free days	28 days	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	28 days	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	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.
the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter	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.
mortality at 90 days	90 days	mortality at 90 days after diagnosis of shock

Trial Locations

Locations (1)

Second Affiliated Hospital Medical College, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China