Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoring Methods

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Centro de Estudos Mário César de Rezende.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro de Estudos Mário César de Rezende
ClinicalTrials.gov Identifier:
NCT00375271
First received: September 11, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Postoperative Care
Procedure: perioperative hemodynamic optimization protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controled Trial of Perioperative Hemodynamic Optimization in High-Risk Patients Using Less-Invasive Monitoringng Methods

Resource links provided by NLM:


Further study details as provided by Centro de Estudos Mário César de Rezende:

Primary Outcome Measures:
  • 60 days mortality

Secondary Outcome Measures:
  • Organ dysfunction by means of SOFA score,
  • Postoperative complications, and
  • ICU and hospital lenghts of stay.

Estimated Enrollment: 400
Study Start Date: August 2006
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with terminal disease, submitted to palliative surgery;
  • Cardiac failure class IV of NYHA;
  • Chronic renal failure without dyalisis and intolerant to fluids;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375271

Contacts
Contact: Ederlon Rezende, MD 55-11-50888146 ederlon@sti-hspe.com.br
Contact: Renata Andréa P Pereira, RN 55-11-50888192 renata@sti-hspe.com.br

Locations
Brazil
Hospital do Servidor Público Estadual Recruiting
São Paulo, SP, Brazil, 04039901
Contact: Ederlon Rezende, MD    55-11-50888146    ederlon@sti-hspe.com.br   
Contact: Renata Andréa P Pereira, RN    55-11-50888192    renata@sti-hspe.com.br   
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         
Sponsors and Collaborators
Centro de Estudos Mário César de Rezende
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375271     History of Changes
Other Study ID Numbers: CONEP 12523, 25000.185884/2005-15
Study First Received: September 11, 2006
Last Updated: September 11, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Centro de Estudos Mário César de Rezende:
Monitoring, Intraoperative
Hemodynamic Processes
Treatment Protocols

ClinicalTrials.gov processed this record on July 22, 2014