Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

February 18, 2009 updated by: University of Sao Paulo

Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Institute of Orthopedics and Traumatology of HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy starch;
  • Anemia;
  • Dysfunction renal;
  • Heart insufficiency;
  • Morbid obesity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HES expansion plasmatic efficacy
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood transfusion
Time Frame: 24 hours
24 hours
Haemostatic alterations
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 18, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HC524/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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