Circulatory FailurePtcO2-FRNCT02083757
Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients
An observational study of Circulatory Failure, run by Southeast University, China at 1 site in China.
Trial summary
Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Circulatory Failure
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to May 2014
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients for whom the attending physician decided to perform a fluid challenge or presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion for less than 24 hours were eligible to participate in the study.
Who may be able to join
- clinical signs of inadequate tissue perfusion defined as systolic blood pressure < 90 mm Hg or a decrease > 40 mmHg in previously hypertensive patients or the need for vasopressive drugs (dopamine > 5 ug/kg/min or norepinephrine); urine output < 0.5 ml/kg/hr for 2 hrs; tachycardia; presence of skin mottling.
Who cannot join
- pregnancy, age of less than 18 years, contraindication to passive leg raising test, cardiac arrhythmias, cardiogenic pulmonary edema, the presence of abdominal compartment syndrome and refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients
Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.
Read the detailed description
The clinical determination of the intravascular volume can be extremely difficult in critically ill patients. Although hemodynamic maximization was proposed, this approach was associated with a risk of fluid overload and excessive inotropic support. Therefore, fluid optimization was seen as a significant step forward and has been shown to decrease complications. Significant effort has been devoted to defining and developing simple means for predicting fluid responsiveness, i.e. whether the patient will benefit from fluid administration. Passive leg raising (PLR), a bedside performed test, could be used to accurately predict fluid responsiveness in most conditions.
However, most parameters that provide information about fluid responsiveness during volume expansion and PLR are invasive and time-consuming. A completely noninvasive and atraumatic parameter to predict fluid responsiveness might be need urgently. Transcutaneous partial pressure of oxygen (PtcO2), a measure to detect tissue ischemia or inadequate perfusion, might reflect the change in cardiac output, thus predict fluid responsiveness. The purpose of this study was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen in the critically ill patients.
- Conditions
- Circulatory Failure
- Keywords
- Fluid responsiveness; Passive leg raising
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resp | Fluid responsiveness is defined as a change of stroke volume stroke volume ≥ 10% after 250 ml rapid saline infusion in 10 minutes. | |
| Nonresp | Fluid responsiveness is defined as a change of stroke volume stroke volume < 10% after 250 ml rapid saline infusion in 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Noninvasive bioreactance CO monitoring was obtained using the NICOM system (Cheetah Medical, Portland, OR) with four double-electrode stickers placed on the chest wall.
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulatory FailureStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083757
- Sponsor's protocol ID
- 2011ZDllKY03.0
- Acronym
- PtcO2-FR
- Status last verified
- May 2015
- First submitted
- 7 Mar 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu J, Peng X, Pan C, Cai S, Zhang X, Xue M, Yang Y, Qiu H. Fluid responsiveness predicted by transcutaneous partial pressure of oxygen in patients with circulatory failure: a prospective study. Ann Intensive Care. 2017 Dec;7(1):56. doi: 10.1186/s13613-017-0279-0. Epub 2017 May 23.
PubMed 28536944
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02083757
- Acronym / sponsor ID
- PtcO2-FR / 2011ZDllKY03.0
- Conditions
- Circulatory Failure
- Keywords
- Fluid responsiveness; Passive leg raising
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Mar 2014 (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.
Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.
Detailed description
The clinical determination of the intravascular volume can be extremely difficult in critically ill patients. Although hemodynamic maximization was proposed, this approach was associated with a risk of fluid overload and excessive inotropic support. Therefore, fluid optimization was seen as a significant step forward and has been shown to decrease complications. Significant effort has been devoted to defining and developing simple means for predicting fluid responsiveness, i.e. whether the patient will benefit from fluid administration. Passive leg raising (PLR), a bedside performed test, could be used to accurately predict fluid responsiveness in most conditions.
However, most parameters that provide information about fluid responsiveness during volume expansion and PLR are invasive and time-consuming. A completely noninvasive and atraumatic parameter to predict fluid responsiveness might be need urgently. Transcutaneous partial pressure of oxygen (PtcO2), a measure to detect tissue ischemia or inadequate perfusion, might reflect the change in cardiac output, thus predict fluid responsiveness. The purpose of this study was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen in the critically ill patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resp | – | –Fluid responsiveness is defined as a change of stroke volume stroke volume ≥ 10% after 250 ml rapid saline infusion in 10 minutes. |
| Nonresp | – | –Fluid responsiveness is defined as a change of stroke volume stroke volume < 10% after 250 ml rapid saline infusion in 10 minutes. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom the attending physician decided to perform a fluid challenge or presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion for less than 24 hours were eligible to participate in the study.
Key inclusion criteria (1 listed)
- clinical signs of inadequate tissue perfusion defined as systolic blood pressure < 90 mm Hg or a decrease > 40 mmHg in previously hypertensive patients or the need for vasopressive drugs (dopamine > 5 ug/kg/min or norepinephrine); urine output < 0.5 ml/kg/hr for 2 hrs; tachycardia; presence of skin mottling.
Key exclusion criteria (1 listed)
- pregnancy, age of less than 18 years, contraindication to passive leg raising test, cardiac arrhythmias, cardiogenic pulmonary edema, the presence of abdominal compartment syndrome and refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac Output
Time frame: 30min
Noninvasive bioreactance CO monitoring was obtained using the NICOM system (Cheetah Medical, Portland, OR) with four double-electrode stickers placed on the chest wall.
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 27 May 2015.
- Derived from this study: PubMed 28536944Xu J, Peng X, Pan C, Cai S, Zhang X, Xue M, Yang Y, Qiu H. Fluid responsiveness predicted by transcutaneous partial pressure of oxygen in patients with circulatory failure: a prospective study. Ann Intensive Care. 2017 Dec;7(1):56. doi: 10.1186/s13613-017-0279-0. Epub 2017 May 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Failure, run by Southeast University, China at 1 site 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 1 inclusion and 1 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 27 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cardiac Output (time frame: 30min). 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 NCT02083757, which also lists 1 linked publication.
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 27 May 2015.