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Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542516
First Posted: October 11, 2007
Last Update Posted: February 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
Currently the most use solution to volemic reposition in hip replacement arthroplasty is the crystalloid solution. This trial intends to compare two different volemic replacements: HES and Ringer's lactate. This research has been analyzing hemodynamic parameters and the coagulation status before and after the pre-expansion with the solutions above mentioned.

Condition Intervention Phase
Hip Replacement Arthroplasty Drug: Hydroxyethyl Starch Drug: Ringer's lactate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • HES expansion plasmatic efficacy [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Blood transfusion [ Time Frame: 24 hours ]
  • Haemostatic alterations [ Time Frame: 24 hours ]

Enrollment: 48
Study Start Date: September 2006
Study Completion Date: November 2008
Arms Assigned Interventions
Experimental: HES 130/04
Pre-expansion with HES
Drug: Hydroxyethyl Starch
Dosage: 30ml/kg; frequency: one time; duration: 60min
Other Name: Voluven
Active Comparator: Ringer's lactate
Pre-expansion with Ringer's lactate
Drug: Hydroxyethyl Starch
Dosage: 30ml/kg; frequency: one time; duration: 60min
Other Name: Voluven
Drug: Ringer's lactate
Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups

Detailed Description:
This trial is randomized an blind to the physician who is analyzing the results.It has been select adults; both sex; ASA I and II. These patients must be submitted to hip arthroplasty replacement. The anesthesia technique is single shot spinal anesthesia. Primary endpoint: assessment alternative; technique replacement volemic with HES 130/04. Secondary endpoint: haemostatic abnormalities; blood loss; transfusion blood.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients involved: adults, ASA I and II;
  • Surgery: hip replacement arthroplasty.

Exclusion Criteria:

  • Allergy starch;
  • Anemia;
  • Dysfunction renal;
  • Heart insufficiency;
  • Morbid obesity.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542516


Locations
Brazil
Institute of Orthopedics and Traumatology of HCFMUSP
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: José Otávio C Auler Junior, PhD/Chairman Hospital das Clínicas - Medicine School of the University of São Paulo
  More Information

Publications:

Responsible Party: adilson hamaji - supervisor anesthesia institute orthopedic USP, University São Paulo
ClinicalTrials.gov Identifier: NCT00542516     History of Changes
Other Study ID Numbers: HC524/04
First Submitted: October 2, 2007
First Posted: October 11, 2007
Last Update Posted: February 19, 2009
Last Verified: February 2009

Keywords provided by University of Sao Paulo:
Hip Replacement Arthroplasty
Hydroxyethyl Starch
Hemodilution
Hetastarch
Colloids

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes