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

NCT ID: NCT01397188

Last Updated: 2013-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-08-31

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.

Detailed Description

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Conditions

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Shock

Keywords

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PiCCO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PiCCO group

Intervention: Device: Picco- thermodilution catheter

Group Type EXPERIMENTAL

PiCCO

Intervention Type DEVICE

transpulmonary thermodilution technique

sham group

No PiCCO Intervention

Group Type SHAM_COMPARATOR

sham, no intervention

Intervention Type OTHER

no intervention

Interventions

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PiCCO

transpulmonary thermodilution technique

Intervention Type DEVICE

sham, no intervention

no intervention

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li danyang

OTHER

Sponsor Role lead

Responsible Party

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Li danyang

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Second Affiliated Hospital Medical College, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cui Wei, MD

Role: CONTACT

Phone: 86 057187783636

Email: [email protected]

Li Danyang, MD

Role: CONTACT

Phone: 86 13588001291

Email: [email protected]

Facility Contacts

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Cui Wei, MD

Role: primary

Li Danyang, MD

Role: backup

Other Identifiers

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19741016

Identifier Type: -

Identifier Source: org_study_id