Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury

NCT01612013 | Completed

• 1 other identifier: EPM1FU311281
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure

Keywords

N-acetylcysteine; angiography; contrast medium; contrast-induced nephropathy; sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• The development of contrast-induced acute kidney injury based either on the creatinine and/or Cystatin C increase between day 0 and 72 hours.

  The primary end point of the study was the development of contrast-induced acute kidney injury based either on the creatinine and/or Cystatin C increase between day 0 (when contrast media was administered) and 72 hours (creatinine; Cystatin C increase ≥ 0.3 mg/dL increase and/or 10% increase, respectively within 72 hours after contrast media administration).

  72 hours

Secondary Outcomes (1)

• 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.

  72 hours

Study Arms (4)

Intravenous NAC plus saline

ACTIVE COMPARATOR

Acetylcysteine was given via intravenous bolus at a rate of 150 mg/kg over 60 min immediately before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Saline (0.9 percent) was given intravenous at a rate of 1 ml/Kg/h over 60 min prior and followed at the same rate during and for the next 6 hours the procedure.

Drug: Intravenous NAC plus saline; Drug: NAC plus saline

Sodium bicarbonate plus saline

ACTIVE COMPARATOR

Sodium bicarbonate solution (Sodium bicarbonate 8.4%, Equiplex, Brazil) was given by adding fifteen ampoules of sodium bicarbonate (150 mEq of sodium) to 1 L of 5% dextrose. Infusion in bolus began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Drug: Sodium bicarbonate plus saline

NAC plus sodium bicarbonate plus saline

ACTIVE COMPARATOR

Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Sodium bicarbonate solution (150 mEq/L of sodium) was given in bolus began 60 min before contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during and for the next 6 hours of the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Drug: NAC plus sodium bicarbonate plus saline

Saline

PLACEBO COMPARATOR

Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Drug: Saline

Interventions

Sodium bicarbonate plus saline DRUG

Sodium bicarbonate solution (Sodium bicarbonate 8.4%, Equiplex, Brazil) was given by adding fifteen ampoules of sodium bicarbonate (150 mEq of sodium) to 1 L of 5% dextrose. Infusion in bolus began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Sodium bicarbonate plus saline

Intravenous NAC plus saline DRUG

Acetylcysteine (Flucistein 100 mg/ml, Neo Química, Brazil) was given via IV bolus at a rate of 150 mg/kg in 500 ml dextrose 5% over 60 min immediately before contrast exposure and followed by 50 mg/kg in 500 ml dextrose 5% during the contrast exposure and for 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Intravenous NAC plus saline

NAC plus sodium bicarbonate plus saline DRUG

Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during the contrast exposure and for 6 hours after the procedure. Sodium bicarbonate solution(150 mEq of sodium) was began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

NAC plus sodium bicarbonate plus saline

Saline DRUG

Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Saline

NAC plus saline DRUG

Acetylcysteine was given via intravenous bolus at a rate of 150 mg/kg over 60 min immediately before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Saline (0.9 percent) was given intravenous at a rate of 1 ml/Kg/h over 60 min prior and followed at the same rate during and for the next 6 hours the procedure.

Intravenous NAC plus saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Hospital das Forças Armadas, Brazil: collaborator
• InCor Heart Institute: collaborator

Study Sites (1)

Hospital das Forcas Armadas - Fundacao Zerbine - INCOR

Brasília, Federal District, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25254489 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate; 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)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 5, 2012
• Study Start: May 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

BR (1)