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Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00542516
Enrollment
48
Registered
2007-10-11
Start date
2006-09-30
Completion date
2008-11-30
Last updated
2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Replacement Arthroplasty

Keywords

Hip Replacement Arthroplasty, Hydroxyethyl Starch, Hemodilution, Hetastarch, Colloids

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.

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.

Interventions

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

DRUGRinger's lactate

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frame
HES expansion plasmatic efficacy24 hours

Secondary

MeasureTime frame
Blood transfusion24 hours
Haemostatic alterations24 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026