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Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

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ClinicalTrials.gov Identifier: NCT00542516
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Hip Replacement Arthroplasty Drug: Hydroxyethyl Starch Drug: Ringer's lactate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : September 2006
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Blood transfusion [ Time Frame: 24 hours ]
  2. Haemostatic alterations [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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

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 Posted: October 11, 2007    Key Record Dates
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