Renal Function in Patients Submitted to Myocardial Revascularization Surgery

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00905775
• Other study ID #: upeclin/HC/FMB-Unesp-22
• Status: Terminated
• Phase: N/A
• First received: April 28, 2009
• Last updated: June 24, 2015
• Start date: December 2008
• Est. completion date: June 2015

Study information

• Verified date: May 2009
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu	Botucatu	Sao Paulo
Brazil	Upeclin	Botucatu	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Country where clinical trial is conducted

Brazil,