Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia

NCT02148809 | Completed Results

• 1 other identifier: IRB # 13193
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Volume Analysis

Outcome Measures

Primary Outcomes (1)

• Change in Total Blood Volume

  The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.

  preoperatively and 6 hours postoperatively

Other Outcomes (1)

• Change IN Plasma Volume PV

  preoperative and 6 hours postoperatively

Study Arms (1)

Blood Volume Analysis, Fluid

EXPERIMENTAL

Preop I-131 is given and the BVA is performed, 6 hours after surgery the same procedure will be done to compare the TBV at both points

Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements

Interventions

1mL of I-131 Human Serum Albumin is injected prior to the measurements RADIATION

Blood Volume Analysis, Fluid

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (5)

• 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.

  PMID: 10757582 BACKGROUND

• 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.

  PMID: 1574972 BACKGROUND

• 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.

  PMID: 14739801 BACKGROUND

• 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.

  PMID: 8881630 BACKGROUND

• 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.

  PMID: 17496003 BACKGROUND

Results Point of Contact

• Title: Dr. Friedrich Boettner
• Organization: HospitalSS

boettnerf@HSS.edu

2127742127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: July 1, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)