Septic ShockPhase 1/2PiCCONCT01526382
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome
A Phase 1/2 study testing PiCCO monitoring (PULSION) and central venous catheter in people with Septic Shock and Acute Respiratory Distress Syndrome, run by Jinhua Central Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Acute Respiratory Distress Syndrome
- What is being tested?
- PiCCO monitoring (PULSION) and central venous catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2012to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Patients were moribund.
- signed do-not-resuscitation odor.
Trial locations and contacts
2 sites in 1 country.
China2 sites
department of critical care medicine, Jinhua central hospital
Jinhua, Zhejiang, 321000
Traditional Chinese Medical hospital of Jinhua City
Jinhua, Zhejiang, 321000
About this study
Official title: Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory
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.
Read the detailed 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.
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome
- Being tested
- PiCCO monitoring (PULSION), central venous catheter
- Keywords
- septic shock, acute respiratory distress syndrome, transpulmonary thermodilution technique, mortality
- Medical subject headings
- Shock, Septic, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO monitoring (PULSION)Device
Also called PiCCO (pulsion medical system, PULSION PiCCO plus)
Patients are monitored with PiCCO system.
central venous catheterProcedure or surgery
patients in this arm can receive central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Active comparator | patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions Receives: Device: PiCCO monitoring (PULSION) |
| 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. Receives: Procedure: central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
death from any cause before day 30
Measured: 30 days
Secondary outcomes (6)
14 day mortality
patients were followed up for 14 days
Measured: 14 days
ICU length of stay
the time from ICU admission to ICU discharge or death
Measured: 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.
Measured: 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
Measured: up to 30 days
ICU free survival days during 30-day period
ICU free survival days during 30-day period
Measured: 30 days
mechanical ventilation free survival days during 30-day period
mechanical ventilation free survival days during 30-day period
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongheng Zhang, Jinhua Central Hospital
- Investigators
- Zhongheng Zhang, MD, Study chair, Jinhua Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526382
- Sponsor's protocol ID
- ZZH-01
- Acronym
- PiCCO
- Status last verified
- Sep 2012
- First submitted
- 27 Jan 2012
- Last updated
- 4 May 2015
- Results posted
- No
Publications
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.
PubMed 14645314Zhang 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.
PubMed 23374652
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory
- ClinicalTrials.gov ID
- NCT01526382
- Acronym / sponsor ID
- PiCCO / ZZH-01
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome
- Keywords
- septic shock, acute respiratory distress syndrome, transpulmonary thermodilution technique, mortality
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Active comparator | Device: PiCCO monitoring (PULSION)patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions |
| control arm | Placebo comparator | Procedure: central venous catheterPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.
- 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).
Key exclusion criteria (2 listed)
- Patients were moribund.
- signed do-not-resuscitation odor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCCO monitoring (PULSION)Also: PiCCO (pulsion medical system, PULSION PiCCO plus)Patients are monitored with PiCCO system. | Device | intervention arm |
| central venous catheterpatients in this arm can receive central venous catheter | Procedure or surgery | control arm |
Primary outcome
30 day mortality
Time frame: 30 days
death from any cause before day 30
6 secondary outcomes
14 day mortality
Time frame: 14 days
ICU length of stay
Time frame: up to 30 days
days on mechanical ventilation
Time frame: up to 30 days
days of vasoactive agents support
Time frame: up to 30 days
ICU free survival days during 30-day period
Time frame: 30 days
mechanical ventilation free survival days during 30-day period
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Background: PubMed 14645314Richard 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.
- Derived from this study: PubMed 23374652Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongheng Zhang, MD study chair
Jinhua Municipal Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PiCCO monitoring (PULSION) and central venous catheter in people with Septic Shock and Acute Respiratory Distress Syndrome, run by Jinhua Central Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01526382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.