- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02083757
Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients (PtcO2-FR)
Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Zhongda Hospital Southeast University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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30min
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011ZDllKY03.0
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