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

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

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 Overview

• Status: Unknown
• Conditions: Shock
• Intervention / Treatment: Device: PiCCO; Other: sham, no intervention

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cui Wei, MD; Phone Number: 86 057187783636; Email: iamcuiwei@gmail.com
• Study Contact Backup: Name: Li Danyang, MD; Phone Number: 86 13588001291; Email: elidanyang@gmail.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital Medical College, Zhejiang University
      • Contact: Cui Wei, MD; Phone Number: +86 0571 87783636; Email: iamcuiwei@gmail.com
      • Contact: Li Danyang, MD; Phone Number: +86 13588001291; Email: elidanyang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Li danyang

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: July 8, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): August 22, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: PiCCO
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 19741016