Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit
This study is not yet open for participant recruitment.
Verified June 2011 by Zhejiang University
Sponsor:
Zhejiang University
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01397188
First received: July 8, 2011
Last updated: August 15, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Shock |
Device: PiCCO Other: sham, no intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU |
Resource links provided by NLM:
Further study details as provided by Zhejiang University:
Primary Outcome Measures:
- mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]mortality at 28 days after diagnosis of shock
Secondary Outcome Measures:
- vasoactive agents-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]vasoactive agents-free days: the number of days fromday 1 to day 28 without use of vasoactive agents.
- intensive care unit-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]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 Natrieutic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter [ Time Frame: 7 days ] [ Designated as safety issue: No ]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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]mortality at 90 days after diagnosis of shock
| Estimated Enrollment: | 320 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PiCCO group
Intervention: Device: Picco- thermodilution catheter
|
Device: PiCCO
transpulmonary thermodilution technique
|
|
Sham Comparator: sham group
No PiCCO Intervention
|
Other: sham, no intervention
no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397188
Contacts
| Contact: Cui Wei, MD | 86 057187783636 | iamcuiwei@gmail.com |
| Contact: Li Danyang, MD | 86 13588001291 | elidanyang@gmail.com |
Locations
| China, Zhejiang | |
| Second Affiliated Hospital Medical College, Zhejiang University | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| Contact: Cui Wei, MD +86 0571 87783636 iamcuiwei@gmail.com | |
| Contact: Li Danyang, MD +86 13588001291 elidanyang@gmail.com | |
Sponsors and Collaborators
Zhejiang University
More Information
No publications provided
| Responsible Party: | Cuiwei, Department of ICU, Second Affiliated Hospital, School of Medicine, Zhejiang University |
| ClinicalTrials.gov Identifier: | NCT01397188 History of Changes |
| Other Study ID Numbers: | 19741016 |
| Study First Received: | July 8, 2011 |
| Last Updated: | August 15, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Zhejiang University:
|
PiCCO |
Additional relevant MeSH terms:
|
Shock Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013