N-acetylcysteine to Prevent Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Instituto do Coracao.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Instituto do Coracao
ClinicalTrials.gov Identifier:
NCT01359722
First received: May 18, 2011
Last updated: May 24, 2011
Last verified: October 2009

May 18, 2011
May 24, 2011
March 2010
December 2011   (final data collection date for primary outcome measure)
Decrease in glomerular filtration defined by at least 30% compared to preoperative levels . [ Time Frame: Within the first 72 hours postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01359722 on ClinicalTrials.gov Archive Site
  • Up 50% of preoperative levels of serum creatinine. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Death from any cause. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Need for dialysis [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Cardiovascular morbidity. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Increased levels of Cystatin C. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Increased levels of NGAL. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
  • Increased levels of isoprostane. [ Time Frame: Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
N-acetylcysteine to Prevent Renal Failure
N-acetylcysteine to Prevent Renal Failure in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Surgery

The purpose of this study is to determine the possible effect nephroprotective of N-acetylcysteine ​​in patients with chronic kidney disease undergoing elective coronary artery bypass grafting by serial evaluation of renal function and to evaluate whether treatment reduces cardiac mortality, cardiac events and Global mortality, if it interferes with oxidative stress and inflammation and the need for dialysis.

Renal failure is a serious and relatively frequent complication of cardiac surgery was observed, especially in diabetics and those with pre-existing renal dysfunction. Given that oxidative stress is elevated in diabetics and in renal and heart, it is reasonable to speculate on its involvement in the pathophysiology of this complication. It is unknown whether the incidence of postoperative renal failure can be reduced by antioxidants. N-acetylcysteine ​​(NAC) is an antioxidant that prevents nephropathy induced by contrast medium and aminoglycosides and increases intracellular levels of cyclic guanosine monophosphate, acting as a vasodilator and platelet inhibitor.

Based on a knowledge of the pathophysiology of ARF, several interventions have been attempted over the past decades. However, various measures employed successfully in the prevention of experimental ARF did not result in success in clinical practice. Much of this failure is probably due to the difference between the experimental models of ARF that encountered in the clinic. Other factors that should be considered, and that may explain the poor results in clinical trials are: the time of use of the drug, dosage and route of administration, are not always adequate.

From the data in the literature, it remains doubtful whether the protective role of NAC is limited only to contrast nephropathy or whether it could have application in other clinical situations in which oxidative stress and vasoconstriction are determinants of injury, as occurs, for example, in CABG surgeries.

NAC is a drug of low cost and low toxicity, this paper intend to assess its role as prophylaxis of renal dysfunction in the postoperative period of CABG in patients with chronic kidney disease stages 3 and 4 (GFR between 15 and 59 mL/min/1, 73 m2 of body surface).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Kidney Failure, Acute
  • Oxidative Stress Induction
  • Drug: N-acetylcysteine
    N-acetylcysteine ​​is administered at a dose of 150mg/kg in 500mL of saline EV in 1 hour followed by a dose of 50mg/kg in 500 mL of saline IV within 6 hours, beginning the infusion together to surgery.
    Other Name: Fluimucil
  • Drug: Control
    The control group will receive only the infusion of saline in the same doses and infusion rate.
    Other Name: saline
  • Experimental: N-Acetylcysteine
    N-acetylcysteine ​​is administered at a dose of 150mg/kg in 500mL of saline EV in 1 hour followed by a dose of 50mg/kg in 500 mL of saline IV within 6 hours, beginning the infusion together to surgery.
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Control
    This group will receive only the infusion of saline in the same doses and infusion rate.
    Intervention: Drug: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients aged 30 to 80 years old of both sexes
  • indicated for elective CABG
  • with glomerular filtration rate, assessed with the MDRD <60 mL/min/1, 73 m2 and> 15 mL / min / 1.73 m2 body surface

Exclusion Criteria:

  • patients on chronic dialysis or with creatinine> 5 mg / dL preoperatively; individuals allergic or intolerant to N-acetylcysteine
  • pregnant women
  • patients with cancer
  • patients underwent re-surgery within the first 72 hours postoperatively
Both
30 Years to 80 Years
No
Contact: Jose Jayme G de Lima, phD +5511-30695048 eduesley.santos@incor.usp.br
Brazil
 
NCT01359722
0992/09
Yes
José Jayme Galvão de Lima, Instituto do Coracao
Instituto do Coracao
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Jose Jayme G de Lima, phD Instito do Coracao-HCFMUSP
Instituto do Coracao
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP