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Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients (PtcO2-FR)

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ClinicalTrials.gov Identifier: NCT02083757
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

Brief Summary:
Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.

Condition or disease
Circulatory Failure

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.

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Study Type : Observational
Actual Enrollment : 19 participants
Time Perspective: Prospective
Official Title: Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Group/Cohort
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.



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083757


Locations
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China, Jiangsu
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jingyuan,Xu, Zhongda Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT02083757    
Other Study ID Numbers: 2011ZDllKY03.0
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Jingyuan,Xu, Southeast University, China:
Fluid responsiveness; Passive leg raising
Additional relevant MeSH terms:
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Shock
Pathologic Processes