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

Septic Shock Clinical Trial

— PiCCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526382
• Other study ID #: ZZH-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 27, 2012
• Last updated: April 30, 2015
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2012
• Source: Jinhua Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Critical Illness
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• PiCCO monitoring (PULSION)
Patients are monitored with PiCCO system.

Procedure:
• central venous catheter
patients in this arm can receive central venous catheter

Locations

Country	Name	City	State
China	department of critical care medicine, Jinhua central hospital	Jinhua	Zhejiang
China	Traditional Chinese Medical hospital of Jinhua City	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jinhua Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Richard C, Warszawski J, Anguel N, Deye N, Combes A, Barnoud D, Boulain T, Lefort Y, Fartoukh M, Baud F, Boyer A, Brochard L, Teboul JL; French Pulmonary Artery Catheter Study Group. Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2713-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day mortality	death from any cause before day 30	30 days	Yes
Secondary	14 day mortality	patients were followed up for 14 days	14 days	No
Secondary	ICU length of stay	the time from ICU admission to ICU discharge or death	up to 30 days	No
Secondary	days on mechanical ventilation	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.	up to 30 days	No
Secondary	days of vasoactive agents support	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	up to 30 days	No
Secondary	ICU free survival days during 30-day period	ICU free survival days during 30-day period	30 days	Yes
Secondary	mechanical ventilation free survival days during 30-day period	mechanical ventilation free survival days during 30-day period	28 days	Yes