Postoperative CareNCT00375271
Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoring Methods
A study testing perioperative hemodynamic optimization protocol in people with Postoperative Care, run by Centro de Estudos Mário César de Rezende at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate different strategies of hemodynamic optimization in high risk surgical patients during the first twelve postoperative hours in ICU based on a protocol guided by a less invasive monitorig tool (Vigileo®), oriented by a fiberoptic central venous catheter that allows continuous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care
- What is being tested?
- perioperative hemodynamic optimization protocol
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Jun 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- High risk elective surgeries* according to adapted Shoemaker criteria.
- Request of post-operative support by the surgeon and anesthetist.
- Patients that have need of central venous and arterial catheters according to surgeon, critical care physician or anesthetist evaluation.
- Informed consent will be obtained from all patients enrolled or their next of kin.
Who cannot join
- Patients with terminal disease, submitted to palliative surgery;
- Cardiac failure class IV of NYHA;
- Chronic renal failure without dyalisis and intolerant to fluids;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital do Servidor Público Estadual
São Paulo, São Paulo, 04039901
Ederlon Rezende, MD, 55-11-50888146, ederlon@sti-hspe.com.br
Renata Andréa P Pereira, RN, 55-11-50888192, renata@sti-hspe.com.br
About this study
Official title: Multicenter Randomized Controled Trial of Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoringng Methods
The aim of this study is to evaluate different strategies of hemodynamic optimization in high risk surgical patients during the first twelve postoperative hours in ICU based on a protocol guided by a less invasive monitorig tool (Vigileo®), oriented by a fiberoptic central venous catheter that allows continuous monitorig of SvcO2 (PreSep®), and a pressure transducer (FloTrac®) that allows cardiac output calculation by the standard deviation of mean arterial pressure or a standard resuscitation strategy.
Read the detailed description
Patients submitted to high risk surgical procedures generally show a hyperdynamic pattern due to the metabolic response after the surgical trauma. This response is fundamentally dependent on their functional reserve and on the treatment. Data from UK show an aged population with 15 to 30% of mortality in the first thirty days after surgery, generally having respiratory or cardiac co-morbidities1. Identification of these patients besides protocol implementation aiming to an appropriate support is the basic strategy to warrant a better outcome in the post-operative period.
Shoemaker has established the definition criteria to high risk patients at the end of the 80's. Those criteria are accepted until today. He too demonstrated the benefits of hemodynamic optimization in order to achieve "supra-normal" oxygen delivery.
Unfortunately, in the years to come, there was a backlash in this concept due to results of several heterogeneous and misleading studies that cast doubts about the efficacy of that strategy. Heyland, however, observed benefit when the hemodynamic optimization was instituted before the surgery.
In the 90's, support to high risk surgical patients had a new start, with publication of several studies demonstrating reduction on morbidity, mortality, and hospital and ICU lengths of stay. In a recent metaanalysis of twenty one studies, Kern and Shoemaker concluded that there was mortality reduction when hemodynamic optimization was started early before organ dysfunction has ensued. There was greater benefit in those studies where the control group had a 20% mortality or more and when the therapy achieved differences on oxygen delivery between the control and treatment groups.
Despite the strong evidence favoring hemodynamic optimization, as long as the high risk patients are identified, more studies are necessary to better answer some questions such as: what is the importance of volemic replacement, what is the best solution to be used, and what is the best method for monitoring for the patient response. Catecholamines must be used carefully, despite their theoretic capacity of modulating inflammatory response. It appears that optimization has to be done early in the pre-operative period when organ dysfunction has not ensued yet. We have to discover for how long the optimization has to be maintained during and after the surgery.
- Conditions
- Postoperative Care
- Being tested
- perioperative hemodynamic optimization protocol
- Keywords
- Monitoring, Intraoperative, Hemodynamic Processes, Treatment Protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperative hemodynamic optimization protocolProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
60 days mortality
Secondary outcomes (3)
Organ dysfunction by means of SOFA score,
Postoperative complications, and
ICU and hospital lenghts of stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startAug 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Centro de Estudos Mário César de Rezende
- Sponsor type
- University, hospital or other
- Investigators
- Ederlon Rezende, MD, Study chair, Hospital do Servidor Publico EstadualÁlvaro Réa-Neto, MD, Principal investigator, Hospital de Clínicas da Universidade Federal do ParanáCiro L Mendes, MD, Principal investigator, Hospital Universitário da Universidade Federal da ParaíbaFernando S Dias, MD, Principal investigator, Hospital São Lucas da Pontifice Universidade Católica do Rio Grande do SulJosé Eduardo C Castro, MD, Principal investigator, Hospital Copa D'OrRubens C Costa Filho, MD, Principal investigator, Hospital ProcardíacoSuzana Margareth A Lobo, MD, Principal investigator, Hospital de Base da Faculdade de Medicina de São José do Rio Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375271
- Sponsor's protocol ID
- CONEP 12523
- Other IDs
- 25000.185884/2005-15
- Status last verified
- Sep 2006
- First submitted
- 11 Sep 2006
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controled Trial of Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoringng Methods
- ClinicalTrials.gov ID
- NCT00375271
- Acronym / sponsor ID
- CONEP 12523
- Conditions
- Postoperative Care
- Keywords
- Monitoring, Intraoperative, Hemodynamic Processes, Treatment Protocols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- Centro de Estudos Mário César de RezendeUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Jun 2007
- First posted
- 12 Sep 2006 (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.
The aim of this study is to evaluate different strategies of hemodynamic optimization in high risk surgical patients during the first twelve postoperative hours in ICU based on a protocol guided by a less invasive monitorig tool (Vigileo®), oriented by a fiberoptic central venous catheter that allows continuous monitorig of SvcO2 (PreSep®), and a pressure transducer (FloTrac®) that allows cardiac output calculation by the standard deviation of mean arterial pressure or a standard resuscitation strategy.
Detailed description
Patients submitted to high risk surgical procedures generally show a hyperdynamic pattern due to the metabolic response after the surgical trauma. This response is fundamentally dependent on their functional reserve and on the treatment. Data from UK show an aged population with 15 to 30% of mortality in the first thirty days after surgery, generally having respiratory or cardiac co-morbidities1. Identification of these patients besides protocol implementation aiming to an appropriate support is the basic strategy to warrant a better outcome in the post-operative period.
Shoemaker has established the definition criteria to high risk patients at the end of the 80's. Those criteria are accepted until today. He too demonstrated the benefits of hemodynamic optimization in order to achieve "supra-normal" oxygen delivery.
Unfortunately, in the years to come, there was a backlash in this concept due to results of several heterogeneous and misleading studies that cast doubts about the efficacy of that strategy. Heyland, however, observed benefit when the hemodynamic optimization was instituted before the surgery.
In the 90's, support to high risk surgical patients had a new start, with publication of several studies demonstrating reduction on morbidity, mortality, and hospital and ICU lengths of stay. In a recent metaanalysis of twenty one studies, Kern and Shoemaker concluded that there was mortality reduction when hemodynamic optimization was started early before organ dysfunction has ensued. There was greater benefit in those studies where the control group had a 20% mortality or more and when the therapy achieved differences on oxygen delivery between the control and treatment groups.
Despite the strong evidence favoring hemodynamic optimization, as long as the high risk patients are identified, more studies are necessary to better answer some questions such as: what is the importance of volemic replacement, what is the best solution to be used, and what is the best method for monitoring for the patient response. Catecholamines must be used carefully, despite their theoretic capacity of modulating inflammatory response. It appears that optimization has to be done early in the pre-operative period when organ dysfunction has not ensued yet. We have to discover for how long the optimization has to be maintained during and after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- High risk elective surgeries* according to adapted Shoemaker criteria.
- Request of post-operative support by the surgeon and anesthetist.
- Patients that have need of central venous and arterial catheters according to surgeon, critical care physician or anesthetist evaluation.
- Informed consent will be obtained from all patients enrolled or their next of kin.
Key exclusion criteria (3 listed)
- Patients with terminal disease, submitted to palliative surgery;
- Cardiac failure class IV of NYHA;
- Chronic renal failure without dyalisis and intolerant to fluids;
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 |
|---|---|---|
| perioperative hemodynamic optimization protocol | Procedure or surgery | – |
Primary outcome
60 days mortality
3 secondary outcomes
Organ dysfunction by means of SOFA score,
Postoperative complications, and
ICU and hospital lenghts of stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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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.
Ederlon Rezende, MD study chair
Hospital do Servidor Publico Estadual
Álvaro Réa-Neto, MD principal investigator
Hospital de Clínicas da Universidade Federal do Paraná
Ciro L Mendes, MD principal investigator
Hospital Universitário da Universidade Federal da Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perioperative hemodynamic optimization protocol in people with Postoperative Care, run by Centro de Estudos Mário César de Rezende 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Sep 2006. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ederlon Rezende, MD (55-11-50888146, ederlon@sti-hspe.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60 days mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2006.