Renal Function in Patients Submitted to Myocardial Revascularization Surgery

NCT00905775 | Terminated DMC

• 1 other identifier: upeclin/HC/FMB-Unesp-22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Acute renal insufficiency (ARI) represents a frequent and serious complication in patients submitted to cardiac surgery, and is associated with increases in time of hospitalization, costs, morbidity and mortality. Its incidence varies from 3.5% to 31%. The present study aims to evaluate renal function and oxidative stress in patients submitted to revascularization surgery with extracorporeal circulation (ECC), comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.

Conditions

Coronary Disease

Keywords

Isoflurane;; Propofol; Renal functions tests; Cardiovascular tests; revascularization surgery of the myocardium; extracorporeal circulation

Study Arms (2)

1 Isoflurane

The first group (G1) will be submitted to inhalational general anesthesia with isoflurane (1 CAM, evaluated by expired concentration of isoflurane)

2 Propofol

The second group (G2) to targeted venous general anesthesia controlled with propofol. The targeted concentration of propofol will be kept at the predicted plasma concentration from 1 to 2 µg.ml-1 by means of a Diprifusor® infusion pump. During the interval from 10 minutes preceding ECC initiation to 10 minutes after ECC, the propofol concentration will be increased to 2 or 3 µg.ml-

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Included in present study will be patients of both sexes, aged from 18 to 75 years, submitted to revascularization surgery of the myocardium with the use of extracorporeal circulation, who had consented to participation by signing the Terms of Free and Clear Consent. Patients excluded will be those with a history of hepatic or renal dysfunction, or a history involving acute myocardial infarct; patients that made use of vitamin C and E; patients presenting other cardiac pathologies (valvular, congenital, corrected or not in the same operational act).

You may qualify if:

• both sexes,
• aged from 18 to 75 years,
• submitted to revascularization surgery of the myocardium
• extracorporeal circulation,
• who had consented to participation by signing the Terms of Free and Clear Consent.

You may not qualify if:

• history of hepatic or renal dysfunction,
• history involving acute myocardial infarct
• patients that made use of vitamin C and E;
• patients presenting other cardiac pathologies (valvular, congenital, corrected or not in the same operational act).

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (2)

Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

Location

Upeclin

Botucatu, São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Pedro TG Vianna, MD

  Faculdade de Medicina de Botucatu, Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: May 21, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2009-05

Locations

BR (2)