Renal Function in Patients Submitted to Myocardial Revascularization Surgery

Evaluation of Renal Function and Oxidative Stress in Patients Submitted to Myocardial Revascularization Surgery, With Extracorporeal Circulation, and Anesthesia With Isoflurane or Propofol

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Disease

Detailed Description

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 ECC, comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.The study will be conducted at the Botucatu Medical School (FMB) and will analyze 60 patients, divided into two randomized groups, submitted to revascularization surgery of the myocardium with ECC. The researcher responsible for data collection from patients will not have knowledge of the type of anesthesia being delivered to the patient.Blood samples will be collected by central venous access for dosing of troponin I, troponin T, CKMB, MDA, creatinine, urea, albumin and cystatin C.Renal function will be evaluated by serum cystatin C and creatinine and the estimated glomerular filtration rate (GFR). GFR will be measured by means of serum cystatin C (Larsson's formula) and by serum creatinine through the Cockcroft-Gault formula (CG) and by the MDRD formula (Modification of Diet in Renal Disease).Markers of renal tubular function will be dosed in the urine, including: alkaline phosphatase, γ - glutamyltransferase(γ-GT), β 2 microglobulin, creatinine and urinary cystatin C.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil
      • Faculdade de Medicina de Botucatu
    • Botucatu, Sao Paulo, Brazil
      • UPECLIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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-

Collaborators and Investigators

• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
• Investigators: Principal Investigator: Pedro TG Vianna, MD, Faculdade de Medicina de Botucatu, Unesp

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (ESTIMATE): May 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Propofol; extracorporeal circulation; Isoflurane;; Renal functions tests; Cardiovascular tests; revascularization surgery of the myocardium
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-22