Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

NCT ID: NCT00542516

Last Updated: 2009-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-11-30

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.

Conditions

Hip Replacement Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HES 130/04

Pre-expansion with HES

Group Type: EXPERIMENTAL

Hydroxyethyl Starch

Intervention Type: DRUG

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

Ringer's lactate

Pre-expansion with Ringer's lactate

Group Type: ACTIVE_COMPARATOR

Hydroxyethyl Starch

Intervention Type: DRUG

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

Ringer's lactate

Intervention Type: DRUG

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

Interventions

Hydroxyethyl Starch

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

Intervention Type: DRUG

Ringer's lactate

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

Intervention Type: DRUG

Other Intervention Names

Voluven

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

University São Paulo

Principal Investigators

José Otávio C Auler Junior, PhD/Chairman

Role: STUDY_CHAIR

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

Locations

Institute of Orthopedics and Traumatology of HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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. doi: 10.1097/00000539-200104000-00011.

Reference Type: BACKGROUND

PMID: 11273914 (View on PubMed)

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. doi: 10.1007/BF03019870.

Reference Type: BACKGROUND

PMID: 11132743 (View on PubMed)

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. doi: 10.1097/00000539-200103000-00003.

Reference Type: BACKGROUND

PMID: 11226079 (View on PubMed)

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. doi: 10.1097/00000539-200209000-00007.

Reference Type: BACKGROUND

PMID: 12198032 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 16288182 (View on PubMed)

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. doi: 10.1097/00000539-199701000-00005.

Reference Type: BACKGROUND

PMID: 8988994 (View on PubMed)

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. doi: 10.1097/01.anes.0000265422.07864.37.

Reference Type: BACKGROUND

PMID: 17525586 (View on PubMed)

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. doi: 10.1093/bja/ael312. Epub 2006 Nov 26.

Reference Type: BACKGROUND

PMID: 17130138 (View on PubMed)

Other Identifiers

HC524/04

Identifier Type: -

Identifier Source: org_study_id