Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Active Comparator | patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions |
|
| control arm | Placebo Comparator | Patients in this arm do not receive PiCCO monitoring device to guide fluid management, but central venous catheter can be inserted at the discretion of treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiCCO monitoring (PULSION) | Device | Patients are monitored with PiCCO system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 day mortality | death from any cause before day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 14 day mortality | patients were followed up for 14 days | 14 days |
| ICU length of stay | the time from ICU admission to ICU discharge or death |
Not provided
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:
Acute respiratory distress syndrome:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhongheng Zhang, MD | Jinhua Municipal Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of critical care medicine, Jinhua central hospital | Jinhua | Zhejiang | 321000 | China | ||
| Traditional Chinese Medical hospital of Jinhua City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14645314 | Background | 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. doi: 10.1001/jama.290.20.2713. | |
| 23374652 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided
| ID | Term |
|---|---|
| D062905 | Central Venous Catheters |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| central venous catheter | Procedure | patients in this arm can receive central venous catheter |
|
| up to 30 days |
| 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 |
| 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 |
| ICU free survival days during 30-day period | ICU free survival days during 30-day period | 30 days |
| mechanical ventilation free survival days during 30-day period | mechanical ventilation free survival days during 30-day period | 28 days |
| Jinhua |
| Zhejiang |
| 321000 |
| China |
| Derived |
| Zhang Z, Xu X, Yao M, Chen H, Ni H, Fan H. Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial. Trials. 2013 Feb 1;14:32. doi: 10.1186/1745-6215-14-32. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |