Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05101031
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2021-06-22
Brief Title:
Evaluation of Fluid Volume in Patients With Refractory Hypotension Fresh-ER
Sponsor:
Ivor Douglas
Organization:
Denver Health and Hospital Authority
Study Overview
Official Title:
Evaluation of Fluid Volume in Patients With Refractory Hypotension Fresh-ER
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fresh-ER
Brief Summary:
The objective of the study is to observe the change in hemodynamic variables ie CO SV HR SV as assessed during rapid fluid bolus
Detailed Description:
The Noninvasive Starling SV Baxter Healthcare is a portable non-invasive cardiac output detector system The Starling SV system measures the cardiac output by employing electrical bioreactance Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid In the case of cardiac output measurements the relevant tissue includes the heart and the immediate surrounding volume of the thorax The relevant fluid is blood
The objective of the study is observe the change in hemodynamic variables ie CO SV HR SV as assessed during the initial resuscitation of 30 mlkg of fluid to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration
This study is a prospective feasibility study Patients will be evaluated by the Emergency Room team for InclusionExclusion criteria If the patient is found to fit the study inclusion and exclusion criteria then the fully non-invasive Starling monitor will be applied to the patient and the patients hemodynamic data will be prospectively collected during the initial fluid resuscitation
The objective of the study is observe the change in hemodynamic variables ie CO SV HR SV as assessed during the initial resuscitation of 30 mlkg of fluid to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration
This study is a prospective feasibility study Patients will be evaluated by the Emergency Room team for InclusionExclusion criteria If the patient is found to fit the study inclusion and exclusion criteria then the fully non-invasive Starling monitor will be applied to the patient and the patients hemodynamic data will be prospectively collected during the initial fluid resuscitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None