Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoring Methods
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|ClinicalTrials.gov Identifier: NCT00375271|
Recruitment Status : Unknown
Verified September 2006 by Centro de Estudos Mário César de Rezende.
Recruitment status was: Recruiting
First Posted : September 12, 2006
Last Update Posted : September 12, 2006
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Care||Procedure: perioperative hemodynamic optimization protocol||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Controled Trial of Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoringng Methods|
|Study Start Date :||August 2006|
|Study Completion Date :||June 2007|
- 60 days mortality
- Organ dysfunction by means of SOFA score,
- Postoperative complications, and
- ICU and hospital lenghts of stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375271
|Contact: Ederlon Rezende, MDemail@example.com|
|Contact: Renata Andréa P Pereira, RNfirstname.lastname@example.org|
|Hospital do Servidor Público Estadual||Recruiting|
|São Paulo, SP, Brazil, 04039901|
|Contact: Ederlon Rezende, MD 55-11-50888146 email@example.com|
|Contact: Renata Andréa P Pereira, RN 55-11-50888192 firstname.lastname@example.org|
|Principal Investigator: Alexandre M Ísola, MD|
|Sub-Investigator: João Manoel Silva Jr., MD|
|Sub-Investigator: Luiz André Magno, MD|
|Sub-Investigator: Paulo Sérgio D Urtado, MD|
|Sub-Investigator: Luciano N Sanches, MD|
|Sub-Investigator: Renata Andréa P Pereira, RN|
|Sub-Investigator: Carla M Silva, RN|
|Sub-Investigator: Maria Aparecida O Batista, RN|
|Study Chair:||Ederlon Rezende, MD||Hospital do Servidor Publico Estadual|
|Principal Investigator:||Álvaro Réa-Neto, MD||Hospital de Clínicas da Universidade Federal do Paraná|
|Principal Investigator:||Ciro L Mendes, MD||Hospital Universitário da Universidade Federal da Paraíba|
|Principal Investigator:||Fernando S Dias, MD||Hospital São Lucas da Pontifice Universidade Católica do Rio Grande do Sul|
|Principal Investigator:||José Eduardo C Castro, MD||Hospital Copa D'Or|
|Principal Investigator:||Rubens C Costa Filho, MD||Hospital Procardíaco|
|Principal Investigator:||Suzana Margareth A Lobo, MD||Hospital de Base da Faculdade de Medicina de São José do Rio Preto|