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Clinical Trials/NCT01397188
NCT01397188UnknownNot Applicable

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

Li danyang1 site in 1 country320 target enrollmentStarted: August 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
320
Locations
1
Primary Endpoint
mortality at 28 days

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

mortality at 28 days

Time Frame: 28 days

mortality at 28 days after diagnosis of shock

Secondary Outcomes

  • vasoactive agents-free days(28 days)
  • intensive care unit-free days(28 days)
  • mechanical ventilation-free days(28 days)
  • the change of lactate at 1,3,7 days after the insertion of the Picco catheter(7 days)
  • the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter(7 days)
  • mortality at 90 days(90 days)

Investigators

Sponsor
Li danyang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Li danyang

Dr

Zhejiang University

Study Sites (1)

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