NCT00542516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

October 2, 2007

Last Update Submit

February 18, 2009

Conditions

Hip Replacement Arthroplasty

Keywords

Hip Replacement ArthroplastyHydroxyethyl StarchHemodilutionHetastarchColloids

Outcome Measures

Primary Outcomes (1)

  • HES expansion plasmatic efficacy

    24 hours

Secondary Outcomes (2)

  • Blood transfusion

    24 hours

  • Haemostatic alterations

    24 hours

Study Arms (2)

HES 130/04

EXPERIMENTAL

Pre-expansion with HES

Drug: Hydroxyethyl Starch

Ringer's lactate

ACTIVE COMPARATOR

Pre-expansion with Ringer's lactate

Drug: Hydroxyethyl StarchDrug: Ringer's lactate

Interventions

Hydroxyethyl StarchDRUG

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

Also known as: Voluven
HES 130/04Ringer's lactate
Ringer's lactateDRUG

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

Ringer's lactate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Orthopedics and Traumatology of HCFMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 11273914BACKGROUND

  • 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.

    PMID: 11132743BACKGROUND

  • 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.

    PMID: 11226079BACKGROUND

  • 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.

    PMID: 12198032BACKGROUND

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

    PMID: 16288182BACKGROUND

  • 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.

    PMID: 8988994BACKGROUND

  • 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.

    PMID: 17525586BACKGROUND

  • 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.

    PMID: 17130138BACKGROUND

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4Ringer's Lactate

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • José Otávio C Auler Junior, PhD/Chairman

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 11, 2007

Study Start

September 1, 2006

Study Completion

November 1, 2008

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

BR(1)