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Fenoldopam (Fenoldopam Mesylate) - Summary

 



FENOLDOPAM SUMMARY

FENOLDOPAM MESYLATE INJECTION USP

Fenoldopam Mesylate Injection USP is a dopamine D1-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion.

Adult Patients: Fenoldopam is indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Transition to oral therapy with another agent can begin at anytime after blood pressure is stable during fenoldopam mesylate infusion.

Pediatric Patients: Information related to the indicated use of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.


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NEWS HIGHLIGHTS

Media Articles Related to Fenoldopam

New Consortium Paves The Way For Improved Treatment Of Hypertension And Associated Vascular Complications
Source: Hypertension News From Medical News Today [2009.11.18]
Top Institute Pharma (TI Pharma) has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension (high blood pressure) and associated vascular complications such as heart and kidney failure, myocardial infarction and stroke.

Kids with CKD Often Have Masked Hypertension (CME/CE)
Source: MedPage Today Nephrology [2009.11.13]
Many children with chronic kidney disease may have undetected hypertension, placing them at risk for enlarged hearts and future cardiovascular disease, a cross-sectional study showed.

Key Player Identified In Cascade That Leads To Hypertension-Related Kidney Damage
Source: Hypertension News From Medical News Today [2009.11.06]
A key player in a cascade that likely begins with stress and leads to high blood pressure and kidney damage has been identified by researchers who say the finding may lead to better ways to control both. Medical College of Georgia researchers have found endothelin, a powerful blood vessel constrictor and inflammatory peptide, increases the number of T cells in the kidneys, which helps recruit other immune cells, causing inflammation and destruction.

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

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Published Studies Related to Fenoldopam

The effect of fenoldopam and dopexamine on hepatic blood flow and hepatic function following coronary artery bypass grafting with hypothermic cardiopulmonary bypass. [2009.06]
BACKGROUND: Hypothermic cardiopulmonary bypass is associated with low perfusion state causing a mismatch between demand and supply to various organs such as gut, kidneys and brain. The consequences are thought to be responsible for postoperative complications like systemic inflammatory response, renal failure, neurological injury, etc. Pharmacological agents like dopamine, dopexamine and dobutamine have been used in an attempt to reduce hypoperfusion and hence complications. Fenoldopam, a dopamine analog (DA-1 receptor agonist), has recently been shown to be specific reno-splanchnic vasodilator in animal studies. We studied the haemodynamic effects of fenoldopam and its effect on hepatic blood flow (HBF) during and after cardiopulmonary bypass and compared these with dopexamine... CONCLUSIONS: Fenoldopam infusion induced transient tachycardia, with no augmentation of hepatic blood flow whereas dopexamine induced tachycardia and did not augment hepatic blood flow. Fenoldopam and dopexamine may have hepato-protective effect.

N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. [2008.05]
OBJECTIVE: To determine whether fenoldopam and N-acetylcysteine prevent renal deterioration and improve hospital outcome for patients with chronic renal insufficiency undergoing cardiac surgery... CONCLUSIONS: Perioperative fenoldopam and N-acetylcysteine abrogate the early postoperative decline in renal function of patients who have chronic renal insufficiency, although these agents do not affect other parameters of cardiac surgical outcome.

Fenoldopam and gastric tonometry during orthotopic liver transplantation. [2007.07]
The aim of this study was to evaluate the effects of continuous infusion of fenoldopam on splanchnic perfusion in orthotopic liver transplant (OLT) recipients... CONCLUSION: Patients undergoing OLT have altered splanchnic perfusion related to cirrhosis, surgical manipulation, and fluid shifts during and after surgery. The use of a splanchnic vasodilator drug improved outcomes in these patients.

Fenoldopam vs dopamine as a nephroprotective strategy during living donor kidney transplantation: preliminary data. [2007.07]
Fenoldopam is a selective DA1 agonist with potential nephroprotective capabilities. The aim of this study was to compare the nephroprotective effect of fenoldopam and dopamine during general anesthesia for living donor kidney transplantation... CONCLUSIONS: Fenoldopam compared with dopamine resulted in better nephroprotective effects. No adverse events were recorded, and side effects were minimal. Further studies are necessary to evaluate these data.

Beneficial impact of fenoldopam in critically ill patients with or at risk for acute renal failure: a meta-analysis of randomized clinical trials. [2007.01]
BACKGROUND: Acute kidney injury is common in critically ill patients. Fenoldopam mesylate is a potent dopamine A-1 receptor agonist that increases blood flow to the renal cortex and outer medulla. Because there is uncertainty about the benefits of fenoldopam in such a setting, we performed a systematic review of randomized controlled trials of intensive care unit patients or those undergoing major surgery... CONCLUSION: This analysis suggests that fenoldopam reduces the need for renal replacement and mortality in patients with acute kidney injury. A large, multicenter, appropriately powered trial will need to be performed to confirm these results.

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Clinical Trials Related to Fenoldopam

The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery [Recruiting]
This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.

The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.

Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery [Recruiting]
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.

Fenoldopam and Acute Renal Failure [Recruiting]
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.

Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.

Fenoldopam in Pediatric Cardiac Surgery [Recruiting]
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.

Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass [Recruiting]
Cardiopulmonary bypass for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0. 2% of the cases. Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occur in 1-2% of cases.

Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0. 1 mcg/kg/min.

The experimental hypothesis of this RCT is that the use of fenoldopam may determine a better visceral perfusion during CPB.

more trials >>

Page last updated: 2009-11-18

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