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Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00542516
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
26
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Sep 1, 2006
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: HES 130/04

Pre-expansion with HES

Drug: Hydroxyethyl Starch
Dosage: 30ml/kg; frequency: one time; duration: 60min
Other Names:
  • Voluven

    		•
    Active Comparator: Ringer's lactate

    Pre-expansion with Ringer's lactate

    Drug: Hydroxyethyl Starch
    Dosage: 30ml/kg; frequency: one time; duration: 60min
    Other Names:
  • Voluven

    • Drug: Ringer's lactate
    Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups

    Outcome Measures

    Primary Outcome Measures

    1. HES expansion plasmatic efficacy [24 hours]

    Secondary Outcome Measures

    1. Blood transfusion [24 hours]

    2. Haemostatic alterations [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00542516
    Other Study ID Numbers:
    • HC524/04
    First Posted:
    Oct 11, 2007
    Last Update Posted:
    Feb 19, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Hip Replacement Arthroplasty
    Hydroxyethyl Starch
    Hemodilution
    Hetastarch
    Colloids

    Study Results

    No Results Posted as of Feb 19, 2009