Clinical trial NCT02148809: Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
Official title: Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Volume Analysis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.

The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.

Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels

Detailed description: Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.

Eligibility criteria: Inclusion Criteria:

* Non- inflammatory degenerative joint disease of the hip
* Patients scheduled for unilateral primary total hip arthroplasty
* Age between 50 and 75 years
* Hypotensive Spinal-epidural anesthesia with systolic BP \< 95 and diastolic BP \< 65.
* Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery

Exclusion Criteria:

* Pregnant women or nursing mothers.
* Women of childbearing potential not using adequate birth control methods
* Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
* Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
* Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
* Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
* Congestive Heart Failure (at least one medication to treat congestive heart failure)
* Coronary artery disease (s/p bypass, stent or AMI)
* Kidney insufficiency (creatinine \> 1.5)
* Aortic or mitral valve disease
* Pulmonary hypertension
* Revision Hip Surgery
* Inadequate intravenous fluid substitution within the first 6 hrs (\<3 liters)
* Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time

Primary outcomes:
measure: Change in Total Blood Volume
timeFrame: preoperatively and 6 hours postoperatively
Secondary outcomes:
Other outcomes:
measure: Change IN Plasma Volume PV
timeFrame: preoperative and 6 hours postoperatively
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
citation: Niemi TT, Pitkanen M, Syrjala M, Rosenberg PH. Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty. Acta Anaesthesiol Scand. 2000 Apr;44(4):457-64. doi: 10.1034/j.1399-6576.2000.440418.x.
citation: Hahn RG. Haemoglobin dilution from epidural-induced hypotension with and without fluid loading. Acta Anaesthesiol Scand. 1992 Apr;36(3):241-4. doi: 10.1111/j.1399-6576.1992.tb03457.x.
citation: Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
citation: Drobin D, Hahn RG. Time course of increased haemodilution in hypotension induced by extradural anaesthesia. Br J Anaesth. 1996 Aug;77(2):223-6. doi: 10.1093/bja/77.2.223.
citation: Manzone TA, Dam HQ, Soltis D, Sagar VV. Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study. J Nucl Med Technol. 2007 Jun;35(2):55-63; quiz 77, 79. doi: 10.2967/jnmt.106.035972. Epub 2007 May 11.