Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- HES expansion plasmatic efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients involved: adults, ASA I and II;
- •Surgery: hip replacement arthroplasty.
Exclusion Criteria
- •Allergy starch;
- •Dysfunction renal;
- •Heart insufficiency;
- •Morbid obesity.
Arms & Interventions
HES 130/04
Pre-expansion with HES
Intervention: Hydroxyethyl Starch (Drug)
Ringer's lactate
Pre-expansion with Ringer's lactate
Intervention: Hydroxyethyl Starch (Drug)
Ringer's lactate
Pre-expansion with Ringer's lactate
Intervention: Ringer's lactate (Drug)
Outcomes
Primary Outcomes
HES expansion plasmatic efficacy
Time Frame: 24 hours
Secondary Outcomes
- Blood transfusion(24 hours)
- Haemostatic alterations(24 hours)