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

Primary Purpose

Acute Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sodium bicarbonate plus saline
Intravenous NAC plus saline
NAC plus sodium bicarbonate plus saline
Saline
NAC plus saline
NAC plus sodium bicarbonate plus saline
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Renal Failure focused on measuring N-acetylcysteine, angiography, contrast medium, contrast-induced nephropathy, sodium bicarbonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital das Forcas Armadas - Fundacao Zerbine - INCOR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intravenous NAC plus saline

Sodium bicarbonate plus saline

NAC plus sodium bicarbonate plus saline

Saline

Arm Description

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.

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.

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.

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.

Outcomes

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.
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.

Full Information

First Posted
May 30, 2012
Last Updated
June 4, 2012
Sponsor
Federal University of São Paulo
Collaborators
Hospital das Forças Armadas, Brazil, InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01612013
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Hospital das Forças Armadas, Brazil, InCor Heart Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
N-acetylcysteine, angiography, contrast medium, contrast-induced nephropathy, sodium bicarbonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous NAC plus saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sodium bicarbonate plus saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NAC plus sodium bicarbonate plus saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate plus saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous NAC plus saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NAC plus sodium bicarbonate plus saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NAC plus saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NAC plus sodium bicarbonate plus saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The development of contrast-induced acute kidney injury based either on the creatinine and/or Cystatin C increase between day 0 and 72 hours.
Description
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).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hospital das Forcas Armadas - Fundacao Zerbine - INCOR
City
Brasilia
State/Province
DF
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25254489
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.
Results Reference
derived

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

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