COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT

NCT00497328 | Completed Phase 2 DMC

• 1 other identifier: SQCIN01
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised controlled trial to investigate the efficacy of preventive regimen of hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR 15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD formula)) undergoing elective percutaneous coronary intervention (PCI).

Conditions

Contrast Induced Nephropathy

Keywords

contrast induced nephropathy

Outcome Measures

Primary Outcomes (1)

• Development of contrast induced nephropathy (defined as >25% rise in baseline creatinine 48 hours post coronary intervention)

  48 hours

Secondary Outcomes (1)

• • Maximum change in serum creatinine level • Difference in hospital stay between groups • Need for hemodialysis • mortality • Maximum change in GFR • Peak creatinine level

  30 days

Study Arms (3)

N-acetylcysteine Group (NAC)

OTHER

N-acetylcysteine Group (NAC) Intravenous infusion 154mEq/L of sodium chloride (0.9% normal saline) at a rate of 1mL/kg/hour from 12 hours before till 6 hours after cardiac catheterization Oral NAC 1200mg dissolve in 250ml of water twice a day the day before to the day after the procedure (total 6 doses)

Drug: N-acetylcysteine

Sodium Bicarbonate Group (SOB)

OTHER

Sodium Bicarbonate Group (SOB) Intravenous infusion154meq/L sodium bicarbonate in 5% dextrose in water at a rate of 3 mL/kg/hour for 1 hour immediately before radiocontrast injection. For patients weighing more than 110 kg, the initial fluid bolus and drip will be limited to those doses administered to a patient weighing 110 kg. Intravenous infusion154meq/L sodium bicarbonate in 5% dextrose in water at a rate of 1 mL/kg/hour during the contrast exposure and for 6 hours after the procedure

Drug: Sodium Bicarbonate

Combination Group (COM: NAC and SOB)

OTHER

Combination Group (COM: NAC and SOB) Intravenous infusion of 154 meq/l sodium bicarbonate at a rate of 3ml/kg/hour for 1 hour before cardiac catheterization and 1 ml/kg/hour till 6 hours after procedure Oral NAC 1200mg dissolve in 250ml of water twice a day the day before to the day after the procedure (total 6 doses). All patients will be monitored regularly for pulmonary congestion and hemodynamics compromise hourly after PCI for 6 hours and every 4 hour thereafter for 24 hours.

Drug: N-acetylcysteine; Drug: Sodium Bicarbonate

Interventions

N-acetylcysteine DRUG

Combination Group (COM: NAC and SOB); N-acetylcysteine Group (NAC)

Sodium Bicarbonate DRUG

Combination Group (COM: NAC and SOB); Sodium Bicarbonate Group (SOB)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 year
• Glomerular Filtration Rate (GFR) 15-60ml/min calculated by MDRD formula
• Scheduled to undergo elective PCI
• Able to receive 12 hours of pre-hydration
• Written informed consent

You may not qualify if:

• GFR less than 15ml/min or patients diagnosed with end stage renal failure
• Increase in serum creatinine levels of \> 0.5mg/dl or 44umol/l in the previous 24 hours
• Preexisting dialysis
• Pulmonary edema or moderate to severe congestive heart failure (New York Heart
• Association \[NYHA\] III-IV)
• Patient unable to withstand the fluid load and hemodynamics compromise
• Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 100mmHg.)
• Emergency cardiac catheterization (i.e. patient presenting with ST segment elevation myocardial infarction undergoing primary angioplasty)
• Recent exposure to radiographic contrast (within two days of the study).
• Allergic to radio-contrast
• Administration of sodium bicarbonate solution or NAC within 48 hours before the PCI.
• Patient unable to give consent
• Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis
• Use of NSAID, aminoglycocide, cyclosporin, cysplatin within 48 hours prior to PCI and throughout the study duration

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

The Heart Institute

Singapore, 119074, Singapore

Location

Related Publications (1)

• Chong E, Poh KK, Lu Q, Zhang JJ, Tan N, Hou XM, Ong HY, Azan A, Chen SL, Chen JY, Ali RM, Fang WY, Lau TW, Tan HC. Comparison of combination therapy of high-dose oral N-acetylcysteine and intravenous sodium bicarbonate hydration with individual therapies in the reduction of Contrast-induced Nephropathy during Cardiac Catheterisation and Percutaneous Coronary Intervention (CONTRAST): A multi-centre, randomised, controlled trial. Int J Cardiol. 2015 Dec 15;201:237-42. doi: 10.1016/j.ijcard.2015.07.108. Epub 2015 Aug 5.

  PMID: 26301645 DERIVED

MeSH Terms

Interventions

Acetylcysteine; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Huay C Tan, FAMS FSCAI

  The Heart Institute, National University Hospital of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

SG (1)