COmbined N-Acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT (CONTRAST)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National University Hospital, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00497328
First received: July 4, 2007
Last updated: May 8, 2008
Last verified: May 2008
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Contrast Induced Nephropathy |
Drug: N-acetylcysteine Drug: Sodium Bicarbonate |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open Labelled Randomized Multi-Center Study of COmbined N-Acetylcysteine and Bicarbonate in PCI To Reduce Incidence of Contrast Induced Nephropathy |
Resource links provided by NLM:
Further study details as provided by National University Hospital, Singapore:
Primary Outcome Measures:
- Development of contrast induced nephropathy (defined as >25% rise in baseline creatinine 48 hours post coronary intervention) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- • Maximum change in serum creatinine level • Difference in hospital stay between groups • Need for hemodialysis • mortality • Maximum change in GFR • Peak creatinine level [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 630 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497328
Contacts
| Contact: Huay C Tan, FAMS FSCAI | 65-67725213 | Huay_Cheem_TAN@nuh.com.sg |
| Contact: Eric Chong, MRCP | 65-93827396 | ericchong80@hotmail.com |
Locations
| Singapore | |
| The Heart Institute | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Huay C Tan, MAMS FSCAI 65-67725213 Huay_Cheem_TAN@nuh.com.sg | |
| Contact: Eric Chong, MRCP 65-93827396 ericchong80@hotmail.com | |
| Principal Investigator: Huay C Tan, FAMS FSCAI | |
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
| Principal Investigator: | Huay C Tan, FAMS FSCAI | The Heart Institute, National University Hospital of Singapore |
More Information
No publications provided
| Responsible Party: | Huay C Tan, FAMS FSCAI, The Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00497328 History of Changes |
| Other Study ID Numbers: | SQCIN01 |
| Study First Received: | July 4, 2007 |
| Last Updated: | May 8, 2008 |
| Health Authority: | Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) |
Keywords provided by National University Hospital, Singapore:
|
contrast induced nephropathy |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 21, 2013