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

Primary Purpose

Shock

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PiCCO
sham, no intervention
Sponsored by
Li danyang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring PiCCO

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Second Affiliated Hospital Medical College, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PiCCO group

sham group

Arm Description

Intervention: Device: Picco- thermodilution catheter

No PiCCO Intervention

Outcomes

Primary Outcome Measures

mortality at 28 days
mortality at 28 days after diagnosis of shock

Secondary Outcome Measures

vasoactive agents-free 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
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
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
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
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
mortality at 90 days after diagnosis of shock

Full Information

First Posted
July 8, 2011
Last Updated
August 20, 2013
Sponsor
Li danyang
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1. Study Identification

Unique Protocol Identification Number
NCT01397188
Brief Title
Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit
Acronym
PiCCO
Official Title
Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li danyang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
PiCCO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PiCCO group
Arm Type
Experimental
Arm Description
Intervention: Device: Picco- thermodilution catheter
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
No PiCCO Intervention
Intervention Type
Device
Intervention Name(s)
PiCCO
Intervention Description
transpulmonary thermodilution technique
Intervention Type
Other
Intervention Name(s)
sham, no intervention
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
mortality at 28 days
Description
mortality at 28 days after diagnosis of shock
Time Frame
28 days
Secondary Outcome Measure Information:
Title
vasoactive agents-free days
Description
vasoactive agents-free days: the number of days from day 1 to day 28 without use of vasoactive agents.
Time Frame
28 days
Title
intensive care unit-free days
Description
intensive care unit(ICU) free days, defined as the number of days from day 1 to day 28 without ICU stay.
Time Frame
28 days
Title
mechanical ventilation-free days
Description
ventilator free days: the number of days from day 1 to day 28 during which the patient breathed spontaneously
Time Frame
28 days
Title
the change of lactate at 1,3,7 days after the insertion of the Picco catheter
Description
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.
Time Frame
7 days
Title
the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter
Description
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.
Time Frame
7 days
Title
mortality at 90 days
Description
mortality at 90 days after diagnosis of shock
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cui Wei, MD
Phone
86 057187783636
Email
iamcuiwei@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Danyang, MD
Phone
86 13588001291
Email
elidanyang@gmail.com
Facility Information:
Facility Name
Second Affiliated Hospital Medical College, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cui Wei, MD
Phone
+86 0571 87783636
Email
iamcuiwei@gmail.com
First Name & Middle Initial & Last Name & Degree
Li Danyang, MD
Phone
+86 13588001291
Email
elidanyang@gmail.com

12. IPD Sharing Statement

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

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