Renal Function in Patients Submitted to Myocardial Revascularization Surgery

UPECLIN HC FM Botucatu Unesp

Status: Terminated

Conditions: Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00905775

upeclin/HC/FMB-Unesp-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

60 participants in 2 patient groups

1 Isoflurane

Description:

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

2 Propofol

Description:

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-