Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

Hip Replacement Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542516
• Other study ID #: HC524/04
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2007
• Last updated: February 18, 2009
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Replacement Arthroplasty

Intervention

Drug:
• Hydroxyethyl Starch
Dosage: 30ml/kg; frequency: one time; duration: 60min
• Ringer's lactate
Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups

Locations

Country	Name	City	State
Brazil	Institute of Orthopedics and Traumatology of HCFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Boldt J, Suttner S. Plasma substitutes. Minerva Anestesiol. 2005 Dec;71(12):741-58. Review. — View Citation

Gallandat Huet RC, Siemons AW, Baus D, van Rooyen-Butijn WT, Haagenaars JA, van Oeveren W, Bepperling F. A novel hydroxyethyl starch (Voluven) for effective perioperative plasma volume substitution in cardiac surgery. Can J Anaesth. 2000 Dec;47(12):1207-15. — View Citation

Gandhi SD, Weiskopf RB, Jungheinrich C, Koorn R, Miller D, Shangraw RE, Prough DS, Baus D, Bepperling F, Warltier DC. Volume replacement therapy during major orthopedic surgery using Voluven (hydroxyethyl starch 130/0.4) or hetastarch. Anesthesiology. 2007 Jun;106(6):1120-7. — View Citation

Haisch G, Boldt J, Krebs C, Kumle B, Suttner S, Schulz A. The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery. Anesth Analg. 2001 Mar;92(3):565-71. Retraction in: Anesth Analg. 2011 May;112(5):1225. — View Citation

Jungheinrich C, Scharpf R, Wargenau M, Bepperling F, Baron JF. The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment. Anesth Analg. 2002 Sep;95(3):544-51, table of contents. — View Citation

Langeron O, Doelberg M, Ang ET, Bonnet F, Capdevila X, Coriat P. Voluven, a lower substituted novel hydroxyethyl starch (HES 130/0.4), causes fewer effects on coagulation in major orthopedic surgery than HES 200/0.5. Anesth Analg. 2001 Apr;92(4):855-62. — View Citation

Mielke LL, Entholzner EK, Kling M, Breinbauer BE, Burgkart R, Hargasser SR, Hipp RF. Preoperative acute hypervolemic hemodilution with hydroxyethylstarch: an alternative to acute normovolemic hemodilution? Anesth Analg. 1997 Jan;84(1):26-30. — View Citation

Otsuki DA, Fantoni DT, Margarido CB, Marumo CK, Intelizano T, Pasqualucci CA, Costa Auler JO Jr. Hydroxyethyl starch is superior to lactated Ringer as a replacement fluid in a pig model of acute normovolaemic haemodilution. Br J Anaesth. 2007 Jan;98(1):29-37. Epub 2006 Nov 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HES expansion plasmatic efficacy		24 hours	Yes
Secondary	Blood transfusion		24 hours	Yes
Secondary	Haemostatic alterations		24 hours	Yes