Comparison Between Two Techniques of Volemic Expansion in... | NCT00542516

Studies
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

NCT00542516

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Feb 19, 2009Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Hip Replacement Arthroplasty

Interventions

Hydroxyethyl Starch
Ringer's lactate

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Nov 2008Actual

First Submitted Date

Oct 2, 2007

First Submission Date that Met QC Criteria

Oct 9, 2007

First Posted Date

Oct 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HES 130/04	Experimental	Pre-expansion with HES	Drug: Hydroxyethyl Starch
Ringer's lactate	Active Comparator	Pre-expansion with Ringer's lactate	Drug: Hydroxyethyl Starch Drug: Ringer's lactate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxyethyl Starch	Drug	Dosage: 30ml/kg; frequency: one time; duration: 60min	HES 130/04 Ringer's lactate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HES expansion plasmatic efficacy		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Blood transfusion		24 hours
Haemostatic alterations		24 hours

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José Otávio C Auler Junior, PhD/Chairman	Hospital das Clínicas - Medicine School of the University of São Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Orthopedics and Traumatology of HCFMUSP		São Paulo	São Paulo	05403-010	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11273914	Background	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.
11132743	Background

ID	Term
D006895	Hydroxyethyl Starch Derivatives
C485123	HES 130-0.4
D000077325	Ringer's Lactate

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans