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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shock

Intervention / Treatment
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* Device: PiCCO
* Other: sham, no intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PiCCO group<br>Intervention: Device: Picco- thermodilution catheter | Device: PiCCO<br>* transpulmonary thermodilution technique<br>|
| Sham Comparator: sham group<br>No PiCCO Intervention | Other: sham, no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality at 28 days | mortality at 28 days after diagnosis of shock | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| mortality at 90 days | mortality at 90 days after diagnosis of shock | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PiCCO