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

Li danyang

Status: Unknown

Conditions: Shock

Treatments: Other: sham, no intervention; Device: PiCCO

Study type: Interventional

Funder types: Other

Identifiers

NCT01397188

19741016

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

PiCCO group

Experimental group

Description:

Intervention: Device: Picco- thermodilution catheter

Treatment:

Device: PiCCO

sham group

Sham Comparator group

Description:

No PiCCO Intervention

Treatment:

Other: sham, no intervention