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
  Purpose

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.


Condition Intervention
Kidney Failure, Acute
Oxidative Stress Induction
Drug: N-acetylcysteine
Drug: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: N-acetylcysteine to Prevent Renal Failure in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Instituto do Coracao:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Control
This group will receive only the infusion of saline in the same doses and infusion rate.
Drug: Control
The control group will receive only the infusion of saline in the same doses and infusion rate.
Other Name: saline

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359722

Contacts
Contact: Jose Jayme G de Lima, phD +5511-30695048 eduesley.santos@incor.usp.br

Locations
Brazil
Instituto do Coracao Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Jose Jayme G de Lima, phD    +5511-3069-5048    eduesley.santos@incor.usp.br   
Sub-Investigator: Eduesley S Santos, RN         
Sponsors and Collaborators
Instituto do Coracao
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Jose Jayme G de Lima, phD Instito do Coracao-HCFMUSP
  More Information

Publications:
Responsible Party: José Jayme Galvão de Lima, Instituto do Coracao
ClinicalTrials.gov Identifier: NCT01359722     History of Changes
Other Study ID Numbers: 0992/09
Study First Received: May 18, 2011
Last Updated: May 24, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Coracao:
N-acetylcysteine
Myocardial Revascularization
Acute Renal Failure
Oxidative Stress

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 23, 2014