Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo

NCT03031600 | Unknown DMC

• 1 other identifier: HU0001-16-1-TS14(N16-P10)
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypovolemia; Hypervolemia

Outcome Measures

Primary Outcomes (1)

• 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).

  Actual blood volume is calculated at 36 minutes after start, and estimated blood volume is computed 62 minutes after start.

Study Arms (2)

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.

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.

Diagnostic Test: Hemodilution via hematocrit measurement

Interventions

Radiodilution via Daxor BVA-100 DIAGNOSTIC_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).

Radiodilution via Daxor BVA-100

Hemodilution via hematocrit measurement DIAGNOSTIC_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).

Hemodilution via hematocrit measurement

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Normal body mass index (defined as 18.5-24.9 per guidelines issued by the Centers for Disease Control and Prevention)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Duke University: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Related Publications (15)

• 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.

  PMID: 18813052 BACKGROUND

• D'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.

  PMID: 19731846 BACKGROUND

• Gallagher 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.

  PMID: 25109164 BACKGROUND

• Johnson A, Ahrens T. Stroke volume optimization: the new hemodynamic algorithm. Crit Care Nurse. 2015 Feb;35(1):11-27. doi: 10.4037/ccn2015427.

  PMID: 25639574 BACKGROUND

• Joosten 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.

  PMID: 25435481 BACKGROUND

• Peng 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.

  PMID: 24994571 BACKGROUND

• Ramsingh 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.

  PMID: 23264068 BACKGROUND

• Scheeren 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.

  PMID: 23558909 BACKGROUND

• Aya 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.

  PMID: 23447502 BACKGROUND

• Correa-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.

  PMID: 26206652 BACKGROUND

• Van 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.

  PMID: 21610355 BACKGROUND

• Borovka 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.

  PMID: 24125107 BACKGROUND

• Feldschuh 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.

  PMID: 902387 BACKGROUND

• Feldschuh 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.

  PMID: 17630591 BACKGROUND

• D'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.

  PMID: 25332464 BACKGROUND

MeSH Terms

Conditions

Hypovolemia; Edema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Kenneth A Wofford, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth A Wofford, PhD

CONTACT

301-295-1001; kenneth.wofford@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: May 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: June 30, 2018
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share