Hip Replacement ArthroplastyPhase 4NCT00542516
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty
A Phase 4 study testing Hydroxyethyl Starch and Ringer's lactate in people with Hip Replacement Arthroplasty, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Replacement Arthroplasty
- What is being tested?
- Hydroxyethyl Starch and Ringer's lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients involved: adults, ASA I and II;
- Surgery: hip replacement arthroplasty.
Who cannot join
- Allergy starch;
- Anemia;
- Dysfunction renal;
- Heart insufficiency;
- Morbid obesity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Orthopedics and Traumatology of HCFMUSP
São Paulo, São Paulo, 05403-010
About this study
Official title: Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate
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.
Read the 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
- Being tested
- Hydroxyethyl Starch, Ringer's lactate
- Keywords
- Hip Replacement Arthroplasty, Hydroxyethyl Starch, Hemodilution, Hetastarch, Colloids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl StarchDrug
Also called Voluven
Dosage: 30ml/kg; frequency: one time; duration: 60min
Ringer's lactateDrug
Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups
| Study group | Role | What they receive |
|---|---|---|
| HES 130/04 | Experimental | Pre-expansion with HES Receives: Drug: Hydroxyethyl Starch |
| Ringer's lactate | Active comparator | Pre-expansion with Ringer's lactate Receives: Drug: Hydroxyethyl Starch; Drug: Ringer's lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HES expansion plasmatic efficacy
Measured: 24 hours
Secondary outcomes (2)
Blood transfusion
Measured: 24 hours
Haemostatic alterations
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startSep 2006
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip Replacement ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- José Otávio C Auler Junior, PhD/Chairman, Study chair, Hospital das Clínicas - Medicine School of the University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542516
- Sponsor's protocol ID
- HC524/04
- Status last verified
- Feb 2009
- First submitted
- 2 Oct 2007
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/00000539-200104000-00011.
PubMed 11273914Gallandat 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.
PubMed 11132743Haisch 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.
PubMed 11226079Jungheinrich 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.
PubMed 12198032Boldt J, Suttner S. Plasma substitutes. Minerva Anestesiol. 2005 Dec;71(12):741-58.
PubMed 16288182Mielke 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.
PubMed 8988994Gandhi 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.
PubMed 17525586Otsuki 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.
PubMed 17130138
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate
- ClinicalTrials.gov ID
- NCT00542516
- Acronym / sponsor ID
- HC524/04
- Conditions
- Hip Replacement Arthroplasty
- Keywords
- Hip Replacement Arthroplasty, Hydroxyethyl Starch, Hemodilution, Hetastarch, Colloids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES 130/04 | Experimental | Drug: Hydroxyethyl StarchPre-expansion with HES |
| Ringer's lactate | Active comparator | Drug: Hydroxyethyl Starch, Drug: Ringer's lactatePre-expansion with Ringer's lactate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients involved: adults, ASA I and II;
- Surgery: hip replacement arthroplasty.
Key exclusion criteria (5 listed)
- Allergy starch;
- Anemia;
- Dysfunction renal;
- Heart insufficiency;
- Morbid obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl StarchAlso: VoluvenDosage: 30ml/kg; frequency: one time; duration: 60min | Drug | HES 130/04, Ringer's lactate |
| Ringer's lactateDosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups | Drug | Ringer's lactate |
Primary outcome
HES expansion plasmatic efficacy
Time frame: 24 hours
2 secondary outcomes
Blood transfusion
Time frame: 24 hours
Haemostatic alterations
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
- Background: PubMed 11273914Langeron 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.
- Background: PubMed 11132743Gallandat 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.
- Background: PubMed 11226079Haisch 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.
- Background: PubMed 12198032Jungheinrich 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.
- Background: PubMed 16288182Boldt J, Suttner S. Plasma substitutes. Minerva Anestesiol. 2005 Dec;71(12):741-58.
- Background: PubMed 8988994Mielke 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.
- Background: PubMed 17525586Gandhi 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.
- Background: PubMed 17130138Otsuki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Otávio C Auler Junior, PhD/Chairman study chair
Hospital das Clínicas - Medicine School of the University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxyethyl Starch and Ringer's lactate in people with Hip Replacement Arthroplasty, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HES expansion plasmatic efficacy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00542516, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.