Clinical trial NCT01612013: Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury
Official title: Intravenous High Dose of N-acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Keywords: N-acetylcysteine
angiography
contrast medium
contrast-induced nephropathy
sodium bicarbonate
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Hospital das Forças Armadas, Brazil
name: InCor Heart Institute
First posted: 2012-06-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C serum levels.


Eligibility criteria: Inclusion Criteria:

* eligible patients include individuals aged 18 year or older with normal renal function who were schedule to undergo cardiac catheterization. During the randomized study, consecutive eligible patients schedule for exposure to the ionic, high osmolality (2130 mOsm/Kg) contrast agent Ioxitalamato.

Exclusion Criteria:

* using metformin or nonsteroidal antiinflammatory drugs within the previous 48 hours
* intake of nephrotoxic drugs during the previous seven days
* pregnancy
* lactation
* intravascular administration of an iodinated contrast medium within the previous two days
* emergency catheterization
* pulmonary edema
* acutely decompensate congestive heart failure
* history of serious reactions to iodinated contrast mediums
* renal transplantation
* end-stage renal disease necessitating dialysis

Primary outcomes:
measure: The development of contrast-induced acute kidney injury based either on the creatinine and/or Cystatin C increase between day 0 and 72 hours.
timeFrame: 72 hours
Secondary outcomes:
measure: The secondary end point was development of CI-AKI in a subgroup of high-risk patients, including patients with diabetes mellitus and those with pre-existent kidney disease defined as calculated creatinine clearance < 60 ml/min/1.73m2.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital das Forcas Armadas - Fundacao Zerbine - INCOR
state: DF
Study officials:
References:
citation: Inda-Filho AJ, Caixeta A, Manggini M, Schor N. Do intravenous N-acetylcysteine and sodium bicarbonate prevent high osmolal contrast-induced acute kidney injury? A randomized controlled trial. PLoS One. 2014 Sep 25;9(9):e107602. doi: 10.1371/journal.pone.0107602. eCollection 2014.