HypovolemiaNCT03031600
Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo
A study testing Radiodilution via Daxor BVA-100 and Hemodilution via hematocrit measurement in people with Hypovolemia and Hypervolemia, run by Uniformed Services University of the Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia, Hypervolemia
- What is being tested?
- Radiodilution via Daxor BVA-100 and Hemodilution via hematocrit measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normal body mass index (defined as 18.5-24.9 per guidelines issued by the Centers for Disease Control and Prevention)
Who cannot join
- Otherwise eligible subjects one or more of the following conditions will be excluded from participation due to the potential to alter blood volume, plasma volume, red cell volume, or microvascular circulation: Cardiovascular disease (to include hypertension, congestive heart failure, previous myocardial infarction, valvular heart disease other than asymptomatic mitral valve prolapse, cardiomyopathy, or peripheral vascular disease), endocrine disease (to include syndrome of inappropriate diuretic hormone, diabetes insipidus, hypothyroidism, hyperthyroidism, or diabetes mellitus), adrenal insufficiency or hypersecretion, renal failure or insufficiency, liver disease, history of sepsis, intravenous fluid administration, nausea, vomiting, diarrhea or heat stress injury within 30 days of the test, eating disorders such as bulimia or anorexia nervosa, or current diuretic or antihypertensive medication use.
- Additionally, subjects who are allergic to iodine, albumin, or iodinated I131 albumin, or cannot undergo intravenous catheter placement will be ineligible to participate.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- Determine subject total blood volume using the gold standard DAXOR Blood Volume Analyzer-100 Analysis System (Radiotracer Dilution Technique).
- Compute estimated subject total blood volume using venous blood hematocrit values drawn before and after an intravenous fluid bolus (Hemodilution Technique).
- 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.
- Conditions
- Hypovolemia, Hypervolemia
- Being tested
- Radiodilution via Daxor BVA-100, Hemodilution via hematocrit measurement
- Medical subject headings
- Hypovolemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiodilution via Daxor BVA-100Diagnostic test
The BVA-100 measures the hematocrit and residual plasma radioactivity of each sample in a semi-automated process, and the residual radioactivity is compared from that of the pre-injection sample to determine plasma volume. The plasma volume and BVA-100-measured hematocrit are then used to calculate the red cell volume and actual blood volume. The BVA-100 is FDA approved for blood volume measurement in vivo, has a reported precision of ± 2.5%, and has demonstrated accuracy and specificity in blood volume assessment in clinical and research settings (Van, P.Y., et al., 2011, Borovka, M., et al., 2013).
Hemodilution via hematocrit measurementDiagnostic test
Hemodilution uses the ideal blood volume and serial hematocrit measures drawn before and after administration of a known quantity of IV fluid to estimate blood volume. Ideal blood volume is calculated using the methods described by Feldschuh and colleagues (Feldschuh, J. and Y. Enson, 1977; Feldschuh, J. and S. Katz, 2007). Hematocrit is measured using the Abbot iSTAT point of care testing device and the lab. Urine output is measured in ml. The ideal blood volume, pre and post-bolus hematocrit, fluid bolus volume, and urine output will be used to calculate estimated blood volume using a mathematical model previously described by the investigators (D'Angelo, M., et al., 2015).
| Study group | Role | What they receive |
|---|---|---|
| Radiodilution via Daxor BVA-100 | Active comparator | In study arm 1, actual blood volume will be measured using the Daxor Blood Volume Analyzer-100 (BVA-100). In this technique, the subject is injected with 1 ml of human serum albumin labeled with iodine131 (25 microcuries). A small amount of blood is collected from the subject just before injection and at 12, 18, 24, 30, and 36 min after injection. Receives: Diagnostic Test: Radiodilution via Daxor BVA-100 |
| Hemodilution via hematocrit measurement | Experimental | In study arm 2, estimated blood volume will measured via hemodilution. . A blood sample (5 ml) will be drawn for baseline determination of hematocrit via iSTAT and lab measurement from the non-dominant arm. After the baseline hematocrit blood sample is drawn, a volume of normal saline equivalent to 10% of the subject's ideal blood volume will be administered over a 12-minute period through the dominant arm IV catheter. Twelve minutes after the infusion is complete, a second blood sample (5 ml) will be drawn from the non-dominant arm for determination of post-bolus hematocrit via iSTAT and lab. Subjects will then be asked to void into a urinal, and urine output will be measured in ml. Receives: Diagnostic Test: Hemodilution via hematocrit measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between actual and estimated blood volume
The primary outcome is the agreement between actual blood volume in ml (as measured via radiodilution by the BVA-100) and estimated blood volume (as measured the methods described in arm 2).
Measured: Actual blood volume is calculated at 36 minutes after start, and estimated blood volume is computed 62 minutes after start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 May 2017 (estimated)
- Primary completion31 May 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study will use a prospective validation design. In this design, each subject will experience both estimation methods/arms (radiodilution and hematocrit dilution) in a fixed sequence. The fixed order is necessary, as hematocrit dilution would bias the results of radiodilution by iatrogenically increasing plasma volume as part of the estimation process.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Duke University, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Kenneth A Wofford, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031600
- Sponsor's protocol ID
- HU0001-16-1-TS14(N16-P10)
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
PubMed 18813052D'Angelo MR, Dutton RP. Hemodynamic measurement in the operating room: a review of conventional measures to identify hypovolemia. AANA J. 2009 Aug;77(4):279-84.
PubMed 19731846Gallagher K, Vacchiano C. Reexamining traditional intraoperative fluid administration: evolving views in the age of goal-directed therapy. AANA J. 2014 Jun;82(3):235-42.
PubMed 25109164Johnson A, Ahrens T. Stroke volume optimization: the new hemodynamic algorithm. Crit Care Nurse. 2015 Feb;35(1):11-27. doi: 10.4037/ccn2015427.
PubMed 25639574Joosten A, Alexander B, Cannesson M. Defining goals of resuscitation in the critically ill patient. Crit Care Clin. 2015 Jan;31(1):113-32. doi: 10.1016/j.ccc.2014.08.006.
PubMed 25435481Peng K, Li J, Cheng H, Ji FH. Goal-directed fluid therapy based on stroke volume variations improves fluid management and gastrointestinal perfusion in patients undergoing major orthopedic surgery. Med Princ Pract. 2014;23(5):413-20. doi: 10.1159/000363573. Epub 2014 Jul 3.
PubMed 24994571Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
PubMed 23264068Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
PubMed 23558909Aya HD, Cecconi M, Hamilton M, Rhodes A. Goal-directed therapy in cardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):510-7. doi: 10.1093/bja/aet020. Epub 2013 Feb 27.
PubMed 23447502Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.
PubMed 26206652Van PY, Riha GM, Cho SD, Underwood SJ, Hamilton GJ, Anderson R, Ham LB, Schreiber MA. Blood volume analysis can distinguish true anemia from hemodilution in critically ill patients. J Trauma. 2011 Mar;70(3):646-51. doi: 10.1097/TA.0b013e31820d5f48.
PubMed 21610355Borovka M, Teruya S, Alvarez J, Helmke S, Maurer MS. Differences in blood volume components between hyporesponders and responders to erythropoietin alfa: the heart failure with preserved ejection fraction (HFPEF) anemia trial. J Card Fail. 2013 Oct;19(10):685-91. doi: 10.1016/j.cardfail.2013.08.508.
PubMed 24125107Feldschuh J, Enson Y. Prediction of the normal blood volume. Relation of blood volume to body habitus. Circulation. 1977 Oct;56(4 Pt 1):605-12. doi: 10.1161/01.cir.56.4.605.
PubMed 902387Feldschuh J, Katz S. The importance of correct norms in blood volume measurement. Am J Med Sci. 2007 Jul;334(1):41-6. doi: 10.1097/MAJ.0b013e318063c707.
PubMed 17630591D'Angelo M, Hodgen RK, Wofford K, Vacchiano C. A Theoretical Mathematical Model to Estimate Blood Volume in Clinical Practice. Biol Res Nurs. 2015 Oct;17(5):478-86. doi: 10.1177/1099800414555410. Epub 2014 Oct 20.
PubMed 25332464
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo
- ClinicalTrials.gov ID
- NCT03031600
- Acronym / sponsor ID
- HU0001-16-1-TS14(N16-P10)
- Conditions
- Hypovolemia, Hypervolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Duke University, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine subject total blood volume using the gold standard DAXOR Blood Volume Analyzer-100 Analysis System (Radiotracer Dilution Technique).
- Compute estimated subject total blood volume using venous blood hematocrit values drawn before and after an intravenous fluid bolus (Hemodilution Technique).
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a prospective validation design. In this design, each subject will experience both estimation methods/arms (radiodilution and hematocrit dilution) in a fixed sequence. The fixed order is necessary, as hematocrit dilution would bias the results of radiodilution by iatrogenically increasing plasma volume as part of the estimation process.
| Arm | Type | Receives |
|---|---|---|
| Radiodilution via Daxor BVA-100 | Active comparator | Diagnostic Test: Radiodilution via Daxor BVA-100In study arm 1, actual blood volume will be measured using the Daxor Blood Volume Analyzer-100 (BVA-100). In this technique, the subject is injected with 1 ml of human serum albumin labeled with iodine131 (25 microcuries). A small amount of blood is collected from the subject just before injection and at 12, 18, 24, 30, and 36 min after injection. |
| Hemodilution via hematocrit measurement | Experimental | Diagnostic Test: Hemodilution via hematocrit measurementIn study arm 2, estimated blood volume will measured via hemodilution. . A blood sample (5 ml) will be drawn for baseline determination of hematocrit via iSTAT and lab measurement from the non-dominant arm. After the baseline hematocrit blood sample is drawn, a volume of normal saline equivalent to 10% of the subject's ideal blood volume will be administered over a 12-minute period through the dominant arm IV catheter. Twelve minutes after the infusion is complete, a second blood sample (5 ml) will be drawn from the non-dominant arm for determination of post-bolus hematocrit via iSTAT and lab. Subjects will then be asked to void into a urinal, and urine output will be measured in ml. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Normal body mass index (defined as 18.5-24.9 per guidelines issued by the Centers for Disease Control and Prevention)
Key exclusion criteria (2 listed)
- Otherwise eligible subjects one or more of the following conditions will be excluded from participation due to the potential to alter blood volume, plasma volume, red cell volume, or microvascular circulation: Cardiovascular disease (to include hypertension, congestive heart failure, previous myocardial infarction, valvular heart disease other than asymptomatic mitral valve prolapse, cardiomyopathy, or peripheral vascular disease), endocrine disease (to include syndrome of inappropriate diuretic hormone, diabetes insipidus, hypothyroidism, hyperthyroidism, or diabetes mellitus), adrenal insufficiency or hypersecretion, renal failure or insufficiency, liver disease, history of sepsis, intravenous fluid administration, nausea, vomiting, diarrhea or heat stress injury within 30 days of the test, eating disorders such as bulimia or anorexia nervosa, or current diuretic or antihypertensive medication use.
- Additionally, subjects who are allergic to iodine, albumin, or iodinated I131 albumin, or cannot undergo intravenous catheter placement will be ineligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiodilution via Daxor BVA-100The BVA-100 measures the hematocrit and residual plasma radioactivity of each sample in a semi-automated process, and the residual radioactivity is compared from that of the pre-injection sample to determine plasma volume. The plasma volume and BVA-100-measured hematocrit are then used to calculate the red cell volume and actual blood volume. The BVA-100 is FDA approved for blood volume measurement in vivo, has a reported precision of ± 2.5%, and has demonstrated accuracy and specificity in blood volume assessment in clinical and research settings (Van, P.Y., et al., 2011, Borovka, M., et al., 2013). | Diagnostic test | Radiodilution via Daxor BVA-100 |
| Hemodilution via hematocrit measurementHemodilution uses the ideal blood volume and serial hematocrit measures drawn before and after administration of a known quantity of IV fluid to estimate blood volume. Ideal blood volume is calculated using the methods described by Feldschuh and colleagues (Feldschuh, J. and Y. Enson, 1977; Feldschuh, J. and S. Katz, 2007). Hematocrit is measured using the Abbot iSTAT point of care testing device and the lab. Urine output is measured in ml. The ideal blood volume, pre and post-bolus hematocrit, fluid bolus volume, and urine output will be used to calculate estimated blood volume using a mathematical model previously described by the investigators (D'Angelo, M., et al., 2015). | Diagnostic test | Hemodilution via hematocrit measurement |
Primary outcome
Agreement between actual and estimated blood volume
Time frame: Actual blood volume is calculated at 36 minutes after start, and estimated blood volume is computed 62 minutes after start.
The primary outcome is the agreement between actual blood volume in ml (as measured via radiodilution by the BVA-100) and estimated blood volume (as measured the methods described in arm 2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Background: PubMed 18813052Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
- Background: PubMed 19731846D'Angelo MR, Dutton RP. Hemodynamic measurement in the operating room: a review of conventional measures to identify hypovolemia. AANA J. 2009 Aug;77(4):279-84.
- Background: PubMed 25109164Gallagher K, Vacchiano C. Reexamining traditional intraoperative fluid administration: evolving views in the age of goal-directed therapy. AANA J. 2014 Jun;82(3):235-42.
- Background: PubMed 25639574Johnson A, Ahrens T. Stroke volume optimization: the new hemodynamic algorithm. Crit Care Nurse. 2015 Feb;35(1):11-27. doi: 10.4037/ccn2015427.
- Background: PubMed 25435481Joosten A, Alexander B, Cannesson M. Defining goals of resuscitation in the critically ill patient. Crit Care Clin. 2015 Jan;31(1):113-32. doi: 10.1016/j.ccc.2014.08.006.
- Background: PubMed 24994571Peng K, Li J, Cheng H, Ji FH. Goal-directed fluid therapy based on stroke volume variations improves fluid management and gastrointestinal perfusion in patients undergoing major orthopedic surgery. Med Princ Pract. 2014;23(5):413-20. doi: 10.1159/000363573. Epub 2014 Jul 3.
- Background: PubMed 23264068Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
- Background: PubMed 23558909Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
- Background: PubMed 23447502Aya HD, Cecconi M, Hamilton M, Rhodes A. Goal-directed therapy in cardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):510-7. doi: 10.1093/bja/aet020. Epub 2013 Feb 27.
- Background: PubMed 26206652Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.
- Background: PubMed 21610355Van PY, Riha GM, Cho SD, Underwood SJ, Hamilton GJ, Anderson R, Ham LB, Schreiber MA. Blood volume analysis can distinguish true anemia from hemodilution in critically ill patients. J Trauma. 2011 Mar;70(3):646-51. doi: 10.1097/TA.0b013e31820d5f48.
- Background: PubMed 24125107Borovka M, Teruya S, Alvarez J, Helmke S, Maurer MS. Differences in blood volume components between hyporesponders and responders to erythropoietin alfa: the heart failure with preserved ejection fraction (HFPEF) anemia trial. J Card Fail. 2013 Oct;19(10):685-91. doi: 10.1016/j.cardfail.2013.08.508.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth A Wofford, PhD principal investigator
Uniformed Services University of the Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Radiodilution via Daxor BVA-100 and Hemodilution via hematocrit measurement in people with Hypovolemia and Hypervolemia, run by Uniformed Services University of the Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth A Wofford, PhD (301-295-1001, kenneth.wofford@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between actual and estimated blood volume (time frame: Actual blood volume is calculated at 36 minutes after start, and estimated blood volume is computed 62 minutes after start.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031600, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.