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

This study has been completed.
Sponsor:
Collaborators:
Hospital das Forças Armadas, Brazil
InCor Heart Institute
Information provided by (Responsible Party):
Antonio Jose de Almeida Inda Filho, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01612013
First received: May 30, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Acute Renal Failure
Drug: Sodium bicarbonate plus saline
Drug: Intravenous NAC plus saline
Drug: NAC plus sodium bicarbonate plus saline
Drug: Saline
Drug: NAC plus saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intravenous High Dose of N-acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • The development of contrast-induced acute kidney injury based either on the creatinine and/or Cystatin C increase between day 0 and 72 hours. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • 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. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous NAC plus saline
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
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.
Drug: NAC plus saline
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.
Active Comparator: Sodium bicarbonate plus saline
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
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.
Active Comparator: NAC plus sodium bicarbonate plus saline
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
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.
Drug: NAC plus sodium bicarbonate plus saline
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.
Placebo Comparator: Saline
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612013

Locations
Brazil
Hospital das Forcas Armadas - Fundacao Zerbine - INCOR
Brasilia, DF, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Hospital das Forças Armadas, Brazil
InCor Heart Institute
  More Information

No publications provided

Responsible Party: Antonio Jose de Almeida Inda Filho, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01612013     History of Changes
Other Study ID Numbers: EPM1FU311281
Study First Received: May 30, 2012
Last Updated: June 4, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
N-acetylcysteine
angiography
contrast medium
contrast-induced nephropathy
sodium bicarbonate

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

ClinicalTrials.gov processed this record on October 23, 2014