Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00542516
First received: October 2, 2007
Last updated: February 18, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood transfusion [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Haemostatic alterations [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 2, 2007
Last Updated: February 18, 2009
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Blood Substitutes
Hematologic Agents
Pharmacologic Actions
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014