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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01397188
Acronym
PiCCO
Enrollment
320
Registered
2011-07-19
Start date
2011-08-31
Completion date
2014-08-31
Last updated
2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

Keywords

PiCCO

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.

Interventions

DEVICEPiCCO

transpulmonary thermodilution technique

OTHERsham, no intervention

no intervention

Sponsors

Li danyang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
mortality at 28 days28 daysmortality at 28 days after diagnosis of shock

Secondary

MeasureTime frameDescription
intensive care unit-free days28 daysintensive care unit(ICU) free days, defined as the number of days from day 1 to day 28 without ICU stay.
mechanical ventilation-free days28 daysventilator free days: the number of days from day 1 to day 28 during which the patient breathed spontaneously
vasoactive agents-free days28 daysvasoactive agents-free days: the number of days from day 1 to day 28 without use of vasoactive agents.
the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter7 daysblood 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 days90 daysmortality at 90 days after diagnosis of shock
the change of lactate at 1,3,7 days after the insertion of the Picco catheter7 daysblood 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.

Countries

China

Contacts

Primary ContactCui Wei, MD
iamcuiwei@gmail.com86 057187783636
Backup ContactLi Danyang, MD
elidanyang@gmail.com86 13588001291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026