Clinical trial NCT00905775: Renal Function in Patients Submitted to Myocardial Revascularization Surgery
Official title: Evaluation of Renal Function and Oxidative Stress in Patients Submitted to Myocardial Revascularization Surgery, With Extracorporeal Circulation, and Anesthesia With Isoflurane or Propofol
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Disease
Keywords: Isoflurane;
Propofol
Renal functions tests
Cardiovascular tests
revascularization surgery of the myocardium
extracorporeal circulation
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2009-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu
state: Sao Paulo
city: Botucatu
country: Brazil
facility: Upeclin
state: Sao Paulo
Study officials:
affiliation: Faculdade de Medicina de Botucatu, Unesp
name: Pedro TG Vianna, MD
role: PRINCIPAL_INVESTIGATOR
References: