Skip to main content
OpenTrials
Completed

NCT Number: NCT01526382

Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome

PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Traditional Chinese Medical hospital of Jinhua City, Jinhua, Zhejiang, China

Loading trial locations.

About this study

PiCCO comprises techniques of pulse contour analysis and transpulmonary thermodilution, and can provide important information on hemodynamics and pulmonary functions. It has been widely used in critical care settings for several decades. Together with pulmonary artery catheter (PAC), it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. During last two decades, many well designed clinical trials have been conducted to see whether the use of PAC would benefit patient outcome. The result consistently showed that PAC added no benefit in terms of mortality, ICU length of stay, organ failure free survival days, and the length of mechanical ventilation. Since PiCCO is relatively new to PAC, and its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.

Shock was defined by the presence 4 criteria:

  • Heart rate of at least 90/min;
  • A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation;
  • The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine;
  • at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value).

Acute respiratory distress syndrome:

  • the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower,
  • bilateral pulmonary infiltrates or a chest radiograph consistent with edema;
  • no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation.

Exclusion criteria

  • Patients were moribund.
  • signed do-not-resuscitation odor.

Treatment and study plan

PiCCO monitoring (PULSION)

Device

Patients are monitored with PiCCO system.

Other names: PiCCO (pulsion medical system, PULSION PiCCO plus)

Central venous catheter

Procedure

patients in this arm can receive central venous catheter

Primary outcomes

  1. 30 day mortality

    Time frame: 30 days

    death from any cause before day 30

Secondary outcomes

  1. 14 day mortality

    Time frame: 14 days

    patients were followed up for 14 days

  2. ICU length of stay

    Time frame: up to 30 days

    the time from ICU admission to ICU discharge or death

  3. days on mechanical ventilation

    Time frame: up to 30 days

    days during which the patients are on mechnical ventilation: The criteria for termination of mechanical ventilation: a cooperative patient, recovery from primary disease, hemodynamically stable, adequate and strong cough reflex, positive end-expiratory pressure <5 cmH2O, pressure support <10 cmH2O and the spontaneous breathing trial is successfully passed.

  4. days of vasoactive agents support

    Time frame: up to 30 days

    days during which vasoactive agents are used: The sum of the number of days with one or more vasoactive agents to maintain a mean arterial pressure >60 mmHg

  5. ICU free survival days during 30-day period

    Time frame: 30 days

    ICU free survival days during 30-day period

  6. mechanical ventilation free survival days during 30-day period

    Time frame: 28 days

    mechanical ventilation free survival days during 30-day period

Sponsors and collaborators

Lead sponsor

Jinhua Central Hospital

Other

Registry information

Official study title

Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory

Acronym: PiCCO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.