An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT00122018 |
Recruitment Status :
Completed
First Posted : July 21, 2005
Last Update Posted : November 7, 2014
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Condition or disease | Intervention/treatment | Phase |
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Kidney Failure, Acute Kidney Failure, Chronic Cardiac Surgical Procedures | Drug: N-acetylcysteine Drug: fenoldopam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery. |
Study Start Date : | May 2002 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: NAC
N-acetylcysteine started day prior to surgery, continued through night of surgery
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Drug: N-acetylcysteine
Other Name: Mucomyst |
Experimental: fenoldopam
fenoldopam started at surgery continued for 24 hours
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Drug: fenoldopam
Other Name: Corlopam |
Experimental: NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
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Drug: N-acetylcysteine
Other Name: Mucomyst Drug: fenoldopam Other Name: Corlopam |
Placebo Comparator: Control
Placebo
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- Length of post-operative hospital stay [ Time Frame: 30-day ]
- Length of post-operative critical care stay [ Time Frame: 30-day ]
- Creatinine clearance post-operative days 3, 14, and nadir [ Time Frame: 14 day ]
- Days to post-operative creatinine clearance nadir [ Time Frame: 14 day ]
- Intraoperative and post-operative pressor use (pressor-hours) [ Time Frame: 48 hour ]
- Hospital costs [ Time Frame: 30-day ]
- Mortality [ Time Frame: 30-day ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic creatinine clearance </= 40cc/h
- Pre-operative cardiac surgery
Exclusion Criteria:
- Pre-operative ongoing dialysis
- Nausea and vomiting
- Uncontrolled glaucoma
- Allergy to metabisulfite
- Enrollment in another clinical study within 30 days
- Pregnancy
- Acute renal failure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122018
Principal Investigator: | Linda F Barr, MD | Pulmonary and Critical Care Assoc. of Baltimore |
Responsible Party: | Linda F. Barr, M.D., Primary Investigator, Pulmonary Critical Care Associates of Baltimore |
ClinicalTrials.gov Identifier: | NCT00122018 |
Other Study ID Numbers: |
REPORT |
First Posted: | July 21, 2005 Key Record Dates |
Last Update Posted: | November 7, 2014 |
Last Verified: | November 2014 |
Kidney failure Cardiac Surgery Fenoldopam N-acetylcysteine |
Renal Insufficiency Kidney Failure, Chronic Acute Kidney Injury Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Acetylcysteine Fenoldopam N-monoacetylcystine Antiviral Agents Anti-Infective Agents Expectorants |
Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Antihypertensive Agents Vasodilator Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents |