Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients

Circulatory Failure Clinical Trial

— PtcO2-FR  

Official title:

Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083757
• Other study ID #: 2011ZDllKY03.0
• Status: Completed
• Phase: N/A
• First received: March 7, 2014
• Last updated: May 26, 2015
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Circulatory Failure
• Critical Illness
• Shock

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30min