We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Function in Patients Submitted to Myocardial Revascularization Surgery

This study has been terminated.
(Failure of recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905775
First Posted: May 21, 2009
Last Update Posted: June 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
UPECLIN HC FM Botucatu Unesp
  Purpose
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.

Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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-

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905775


Locations
Brazil
Faculdade de Medicina de Botucatu
Botucatu, Sao Paulo, Brazil
Upeclin
Botucatu, Sao Paulo, Brazil
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Pedro TG Vianna, MD Faculdade de Medicina de Botucatu UNESP
  More Information

Responsible Party: UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT00905775     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-22
First Submitted: April 28, 2009
First Posted: May 21, 2009
Last Update Posted: June 25, 2015
Last Verified: May 2009

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Isoflurane;
Propofol
Renal functions tests
Cardiovascular tests
revascularization surgery of the myocardium
extracorporeal circulation

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation