N-acetylcysteine to Prevent Renal Failure

NCT01359722 | Unknown DMC

• 1 other identifier: 0992/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure, Acute; Oxidative Stress Induction

Keywords

N-acetylcysteine; Myocardial Revascularization; Acute Renal Failure; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Decrease in glomerular filtration defined by at least 30% compared to preoperative levels .

  Within the first 72 hours postoperatively

Secondary Outcomes (7)

• Up 50% of preoperative levels of serum creatinine.

  Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.

• Death from any cause.

  Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.

• Need for dialysis

  Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.

• Cardiovascular morbidity.

  Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.

• Increased levels of Cystatin C.

  Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.

Study Arms (2)

N-Acetylcysteine

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

This group will receive only the infusion of saline in the same doses and infusion rate.

Drug: Control

Interventions

N-acetylcysteine DRUG

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.

Also known as: Fluimucil

N-Acetylcysteine

Control DRUG

The control group will receive only the infusion of saline in the same doses and infusion rate.

Also known as: saline

Control

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Coracao: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Coracao

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (5)

• Suen WS, Mok CK, Chiu SW, Cheung KL, Lee WT, Cheung D, Das SR, He GW. Risk factors for development of acute renal failure (ARF) requiring dialysis in patients undergoing cardiac surgery. Angiology. 1998 Oct;49(10):789-800. doi: 10.1177/000331979804900902.

  PMID: 9783643 BACKGROUND

• Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.

  PMID: 10900277 BACKGROUND

• Shyu KG, Cheng JJ, Kuan P. Acetylcysteine protects against acute renal damage in patients with abnormal renal function undergoing a coronary procedure. J Am Coll Cardiol. 2002 Oct 16;40(8):1383-8. doi: 10.1016/s0735-1097(02)02308-2.

  PMID: 12392825 BACKGROUND

• Mazzon E, Britti D, De Sarro A, Caputi AP, Cuzzocrea S. Effect of N-acetylcysteine on gentamicin-mediated nephropathy in rats. Eur J Pharmacol. 2001 Jul 13;424(1):75-83. doi: 10.1016/s0014-2999(01)01130-x.

  PMID: 11470263 BACKGROUND

• Baker CS, Wragg A, Kumar S, De Palma R, Baker LR, Knight CJ. A rapid protocol for the prevention of contrast-induced renal dysfunction: the RAPPID study. J Am Coll Cardiol. 2003 Jun 18;41(12):2114-8. doi: 10.1016/s0735-1097(03)00487-x.

  PMID: 12821233 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Acetylcysteine; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jose Jayme G de Lima, phD

  Instito do Coracao-HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Jayme G de Lima, phD

CONTACT

+5511-30695048; eduesley.santos@incor.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 25, 2011
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 25, 2011

Record last verified: 2009-10

Locations

BR (1)