Recruitment

Recruitment Status
Completed
Estimated Enrollment
20

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Locations

New York, New York, 10021
New York, New York, 10021

Tracking Information

NCT #
NCT02148809
Collaborators
Not Provided
Investigators
Not Provided
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