Skip to main content
OpenTrials
Completed

NCT Number: NCT00542516

Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Replacement Arthroplasty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Orthopedics and Traumatology of HCFMUSP

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hydroxyethyl starch

Drug

Dosage: 30ml/kg; frequency: one time; duration: 60min

Other names: Voluven

Ringer's Lactate

Drug

Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups

Primary outcomes

  1. HES expansion plasmatic efficacy

    Time frame: 24 hours

Secondary outcomes

  1. Blood transfusion

    Time frame: 24 hours

  2. Haemostatic alterations

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Oct 11, 2007
Registry last updated
Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.