Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-29 @ 5:33 PM
Study NCT ID:
NCT03031600
Status:
UNKNOWN
Last Update Posted:
2017-01-26
First Post:
2017-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Study Overview
Official Title:
Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The objective of this study is to determine the accuracy of estimating patient blood volume using field-expedient point-of-care measurement of hematocrit before and after hemodilution with a standardized volume of intravenous solution, in comparison to determining patient blood volume by radiodilution. A total of 33 healthy adult male subjects aged 18-35 years will undergo determination of blood volume in a fixed order: first by radiodilution, then by hemodilution. Blood volume as measured by radiodilution will be correlated with blood volume as estimated with hemodilution to assess the potential validity of hemodilution as means of estimating blood volume.
Detailed Description:
The primary goal of perioperative fluid therapy is to optimize patient blood volume for a given degree of cardiac function and thereby promote adequate end organ tissue perfusion. In the ideal situation, a surgical patient would maintain a euvolemic total blood volume (TBV) that promotes optimal tissue oxygenation, nutrient supply, and removal of metabolic waste products. Current methods to assess perioperative TBV and manage intravenous (IV) fluids, which include fluid algorithms, physiologic parameters, blood studies, and clinician intuition, are either inaccurate or require highly specialized equipment and training. Therefore, clinicians are faced with the formidable task of attempting to titrate IV fluids with the goal of preserving optimal tissue perfusion in the perioperative period without knowledge of the patient's actual TBV. This long standing clinical conundrum, and the potential iatrogenic consequences of hypo- or hypervolemia, has recently produced a significant degree of inquiry into direct and indirect methods to evaluate cardiac output as a product of fluctuating TBV. The goal of much of this investigation is to generate an evidence-based methodology for administration of perioperative IV fluids to promote euvolemia and preserve adequate tissue perfusion. There is strong evidence from the civilian anesthesia and surgical literature that the use of various indicators of cardiac output as a marker of TBV and a guide for fluid therapy, so called Goal Directed Fluid Therapy (GDFT), leads to significantly better perioperative patient outcomes. However, current GDFT management protocols rely heavily on technology not readily available within or sufficiently ruggedized for use in the military field setting where ongoing accurate estimation of TBV to guide fluid replacement in the presence of major trauma, and its physiologic aftermath, may be critical to survival. Therefore, the primary objective of this study is to assess the accuracy of determining patient TBV using measurement of red blood cell volume (hematocrit, or HCT) with a point-of-care testing device relevant to the military setting, before and after hemodilution with a standard IV solution. The specific aims of the proposed research are to:
1. Determine subject total blood volume using the gold standard DAXOR Blood Volume Analyzer-100 Analysis System (Radiotracer Dilution Technique).
2. Compute estimated subject total blood volume using venous blood hematocrit values drawn before and after an intravenous fluid bolus (Hemodilution Technique).
3. Correlate inter-subject radiotracer dilution technique-derived total blood volume with hemodilution technique-derived total blood volume.
Hypothesis:
The calculated total blood volume derived by a simple clinically applicable hemodilution technique will highly correlate with the gold standard laboratory radiotracer dilution technique.
The proposed study will examine the utility of a simple, clinically applicable, and adaptable method to assess a patient's TBV that does not rely on sophisticated, technology-dependent, direct or indirect measures of cardiac output. Development and confirmation of the accuracy of a simple method to intermittently determine a patient's TBV in the perioperative setting would revolutionize the ability of a practitioner to match perioperative IV fluid administration to the goal of optimizing cardiac output and tissue perfusion. The tremendous potential positive impact of this work on surgical and anesthesia care in both the military and civilian settings is evident in the brief but expansive existing work demonstrating significant improvement in patient outcomes using GDFT techniques. The proposed study is potentially the first step in a future program of research to bring the benefits of GDFT into austere settings.
1. Determine subject total blood volume using the gold standard DAXOR Blood Volume Analyzer-100 Analysis System (Radiotracer Dilution Technique).
2. Compute estimated subject total blood volume using venous blood hematocrit values drawn before and after an intravenous fluid bolus (Hemodilution Technique).
3. Correlate inter-subject radiotracer dilution technique-derived total blood volume with hemodilution technique-derived total blood volume.
Hypothesis:
The calculated total blood volume derived by a simple clinically applicable hemodilution technique will highly correlate with the gold standard laboratory radiotracer dilution technique.
The proposed study will examine the utility of a simple, clinically applicable, and adaptable method to assess a patient's TBV that does not rely on sophisticated, technology-dependent, direct or indirect measures of cardiac output. Development and confirmation of the accuracy of a simple method to intermittently determine a patient's TBV in the perioperative setting would revolutionize the ability of a practitioner to match perioperative IV fluid administration to the goal of optimizing cardiac output and tissue perfusion. The tremendous potential positive impact of this work on surgical and anesthesia care in both the military and civilian settings is evident in the brief but expansive existing work demonstrating significant improvement in patient outcomes using GDFT techniques. The proposed study is potentially the first step in a future program of research to bring the benefits of GDFT into austere settings.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: