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

NCT00375271 | Unknown

• 2 other identifiers: CONEP 1252325000.185884/2005-15
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postoperative Care

Keywords

Monitoring, Intraoperative; Hemodynamic Processes; Treatment Protocols

Outcome Measures

Primary Outcomes (1)

• 60 days mortality

Secondary Outcomes (3)

• Organ dysfunction by means of SOFA score,

• Postoperative complications, and

• ICU and hospital lenghts of stay.

Interventions

perioperative hemodynamic optimization protocol PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with terminal disease, submitted to palliative surgery;
• Cardiac failure class IV of NYHA;
• Chronic renal failure without dyalisis and intolerant to fluids;

Sponsors & Collaborators

• Centro de Estudos Mário César de Rezende: lead

Study Sites (1)

Hospital do Servidor Público Estadual

São Paulo, São Paulo, 04039901, Brazil

RECRUITING

Study Officials

• Ederlon Rezende, MD

  Hospital do Servidor Publico Estadual

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ederlon Rezende, MD

CONTACT

55-11-50888146; ederlon@sti-hspe.com.br

Renata Andréa P Pereira, RN

CONTACT

55-11-50888192; renata@sti-hspe.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 12, 2006
• Study Start: August 1, 2006
• Study Completion: June 1, 2007
• Last Updated: September 12, 2006

Record last verified: 2006-09

Locations

BR (1)