Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hip Replacement Arthroplasty	Drug: Hydroxyethyl Starch Drug: Ringer's lactate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement

Drug Information available for: Lactic acid Ammonium lactate Ringer's lactate Hetastarch

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

HES expansion plasmatic efficacy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood transfusion [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Haemostatic alterations [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	September 2006
Study Completion Date:	November 2008

Arms	Assigned Interventions
Experimental: HES 130/04 Pre-expansion with HES	Drug: Hydroxyethyl Starch Dosage: 30ml/kg; frequency: one time; duration: 60min Other Name: Voluven
Active Comparator: Ringer's lactate Pre-expansion with Ringer's lactate	Drug: Hydroxyethyl Starch Dosage: 30ml/kg; frequency: one time; duration: 60min Other Name: Voluven Drug: Ringer's lactate Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542516

Locations

Brazil
Institute of Orthopedics and Traumatology of HCFMUSP
São Paulo, Brazil, 05403-010

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Chair:

José Otávio C Auler Junior, PhD/Chairman

Hospital das Clínicas - Medicine School of the University of São Paulo

More Information

Publications:

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.

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.

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.

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.

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

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.

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.

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.

Responsible Party:	adilson hamaji - supervisor anesthesia institute orthopedic USP, University São Paulo
ClinicalTrials.gov Identifier:	NCT00542516 History of Changes
Other Study ID Numbers:	HC524/04
Study First Received:	October 2, 2007
Last Updated:	February 18, 2009
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:

Hip Replacement Arthroplasty
Hydroxyethyl Starch
Hemodilution
Hetastarch
Colloids

Additional relevant MeSH terms:

Hetastarch
Plasma Substitutes
Blood Substitutes

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013