Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 20
Inclusion Criteria
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Patients scheduled for unilateral primary total hip arthroplasty
- Non- inflammatory degenerative joint disease of the hip
- ...
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Patients scheduled for unilateral primary total hip arthroplasty
- Non- inflammatory degenerative joint disease of the hip
- Age between 50 and 75 years
- Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery
Exclusion Criteria
- Congestive Heart Failure (at least one medication to treat congestive heart failure)
- Aortic or mitral valve disease
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- ...
- Congestive Heart Failure (at least one medication to treat congestive heart failure)
- Aortic or mitral valve disease
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- Kidney insufficiency (creatinine > 1.5)
- Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
- Revision Hip Surgery
- Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods
- Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
- Inadequate intravenous fluid substitution within the first 6 hrs (<3 liters)
- Pulmonary hypertension
- Coronary artery disease (s/p bypass, stent or AMI)
- Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
Summary
- Conditions
- Blood Volume Analysis
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 50 years and 75 years
- Gender
- Both males and females
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 intraven...
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.
Inclusion Criteria
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Patients scheduled for unilateral primary total hip arthroplasty
- Non- inflammatory degenerative joint disease of the hip
- ...
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Patients scheduled for unilateral primary total hip arthroplasty
- Non- inflammatory degenerative joint disease of the hip
- Age between 50 and 75 years
- Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery
Exclusion Criteria
- Congestive Heart Failure (at least one medication to treat congestive heart failure)
- Aortic or mitral valve disease
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- ...
- Congestive Heart Failure (at least one medication to treat congestive heart failure)
- Aortic or mitral valve disease
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- Kidney insufficiency (creatinine > 1.5)
- Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
- Revision Hip Surgery
- Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods
- Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
- Inadequate intravenous fluid substitution within the first 6 hrs (<3 liters)
- Pulmonary hypertension
- Coronary artery disease (s/p bypass, stent or AMI)
- Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
Tracking Information
- NCT #
- NCT02148809
- Collaborators
- Not Provided
- Investigators
- Not Provided