Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Hip Replacement Arthroplasty

Treatments: Drug: Hydroxyethyl Starch; Drug: Ringer's lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT00542516

HC524/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

HES 130/04

Experimental group

Description:

Pre-expansion with HES

Treatment:

Drug: Hydroxyethyl Starch

Ringer's lactate

Active Comparator group

Description:

Pre-expansion with Ringer's lactate

Treatment:

Drug: Ringer's lactate

Drug: Hydroxyethyl Starch