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Surgical injury is increasing dialysis use - News-Medical.net |
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By Sarah Guy
Acute dialysis use in patients who experience kidney injury while undergoing major elective surgery has increased substantially over the past 14 years, report researchers in the Canadian Medical Association Journal.
Their review of data from patients in Ontario, Canada, also showed an overall increase in patients' age and number of comorbidities, and that dialysis was most common after cardiac and vascular surgery.
Furthermore, Amit Garg (Western University, London, Ontario) and colleagues observed that almost half of patients who received acute dialysis died within 90 days of surgery, and of those who survived, over a quarter required chronic dialysis.
"Our results should prompt renewed efforts to develop and test interventions to prevent severe acute kidney injury and to attenuate the high burden of death and end-stage renal disease after such injury has occurred," writes the team.
The dataset included 552,672 consecutive patients who underwent surgery at 118 hospitals between 1995 and 2009, of whom 2231 (0.4%) received acute dialysis within 2 weeks.
Adjusted analysis revealed a significant rising annual trend in acute dialysis use such that patients in 2009 were 1.7 times more likely to receive it than their counterparts in 1995.
Cardiac and vascular surgeries were most frequently complicated by acute dialysis; experienced by as many as one in 80 and one in 85 patients, respectively.
Patient age and comorbidity status increased over the study period, say the authors. The proportion of those aged 65 years and older rose from 39.5% in 1995?1997 to 50.6% in 2006?2009, and the proportion of patients with diabetes and hypertension increased from 11.1% to 21.4% and 28.9% to 44.8%, respectively, between the same time periods.
A total of 42.0% of patients who received acute dialysis died within 90 days of surgery, and 27.2% of those who survived more than 3 months needed chronic dialysis. The rates of both of these outcomes did not change appreciably over time, note Garg et al.
The team suggests a couple of explanations for their finding of increased dialysis use, including that older and increasingly comorbid patients may be at higher risk for kidney injury, and that the current availability of less invasive alternatives render only those with the worst prognoses as surgical candidates.
"Alternatively, nephrologists today may be consulted earlier in the course of a patients' illness than before, dialysis may be more readily available, and the threshold for starting dialysis may be lower," they conclude.
Licensed from Medwire news with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.
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Similar Outcomes for Robot-Aided Conventional Nephrectomy - Renal Business Today |
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ANN ARBOR, Mich.—Robot-assisted and conventional laparoscopic partial nephrectomies have similar outcomes and complication rates, according to a study published in The Journal of Urology.
Jonathan S. Ellison, MD, of the University of Michigan in Ann Arbor, and colleagues compared perioperative outcomes and complications from conventional laparoscopic and robot-assisted partial nephrectomy cases from January 2007 to June 2010.
Robot-assisted partial nephrectomies were performed by a heterogeneous group of surgeons, while a single experienced laparoscopic surgeon performed the conventional procedures. One hundred eight pairs of patients were matched by age, hilar nature of the tumor, approach, and R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines) nephrometry score.
The researchers found that nephrometry score, age, gender, tumor side, and American Society of Anesthesia physical status classification were similar between the groups. Conventional laparoscopic partial nephrectomy had better operative time. Robot-assisted partial nephrectomy showed significant improvements in estimated blood loss and warm ischemia time compared to the conventional laparoscopic group. The postoperative complication rates and complication distributions by Clavien classification and type were similar for both groups (41.7% for the conventional group and 35 percent for the robot-assisted group).
"Robot-assisted partial nephrectomy has a noticeable but rapid learning curve," the researchers wrote. "After it is overcome the robotic procedure results in perioperative outcomes similar to those achieved with conventional laparoscopic partial nephrectomy done by an experienced surgeon."
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FDA Declares Fresenius Medical Care Warning for GranuFlo, NaturaLyte ... - DigitalJournal.com (press release) |
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New York, New York (PRWEB) June 28, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, reports that the U.S. Food & Drug Administration (FDA) has declared Fresenius Medical Care's recent warning regarding its GranuFlo and NaturaLyte dialysis products to be a Class I recall, the agency's most serious medical device recall category. In March 2012, Fresenius issued an Urgent Product Notification warning its customers that GranuFlo and NaturaLyte are associated with elevated bicarbonate levels, a significant risk factor for cardiac arrest. Parker Waichman LLP first reported on these issues in a press release issued by the firm on June 21, 2012.
According to the FDA, Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.
GranuFlo and NaturaLyte are alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body.
According to the Times, Fresenius is being investigated for failing to warn its customers about the serious risks associated with GranuFlo and NaturaLyte. According to the report, Fresenius had issued an internal memo to its own clinics on November 4, 2011, warning that 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. The company conducted an analysis of these patients, comparing them to over 80,000 other dialysis patients in the same centers. Overall, the data indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.
While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the FDA about the findings until the agency received an anonymous copy of the memo and inquired about it. In May, the FDA issued a Safety Communication warning about alkali dosing errors for products like GranuFlo and NaturaLyte in hemodialysis patients. “Given that Fresenius’ actions or inaction raise concerns as to whether Fresenius is capable of appropriately advising facilities using GranuFlo and NaturaLyte Dialysis Products of their inherent danger, FDA’s Class I recall is a welcomed action,” says Matthew McCauley, Senior Litigation Counsel at Parker Waichman LLP. He also stated that, “by taking this action, FDA essentially ordered Fresenius to take the necessary steps to advise ALL, not just Fresenius owned, facilities using GranuFlo and NaturaLyte Dialysis Products that these products are being investigated for serious safety concerns.”
Parker Waichman LLP offers free lawsuit consultations to victims of Fresenius GranuFlo and NaturaLyte side effects. If you or a loved one experienced sudden cardiac arrest or sudden heart attack following dialysis with GranuFlo or NaturaLyte, please visit the firm's GranuFlo and NaturaLyte injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Fresenius GranuFlo and NaturaLyte lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
Read the full story at http://www.prweb.com/releases/freseniusdialysis/62012/prweb9652817.htm
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Rockwell Medical Announces Canadian Patent Issuance for Proprietary SFP ... - Healthcare Global (press release) |
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WIXOM, MI--(Marketwire - June 27, 2012) - Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has received notice from the Canadian Intellectual Property Office that it has obtained patent issuance for its proprietary drug, Soluble Ferric Pyrophosphate (SFP), the Company's late-stage investigational drug that provides iron replacement to hemodialysis patients with CKD. The Canadian patent grant covers the method and pharmaceutical composition for SFP-iron delivery in hemodialysis and peritoneal dialysis patients.
Mr. Robert L. Chioini, Chairman and CEO of Rockwell stated, "We are pleased to secure patent protection for SFP-iron delivery in an important market such as Canada. In conjunction with the successful completion of our SFP clinical studies, we will continue to evaluate worldwide market opportunities with an established marketing partner for the development and distribution of SFP."
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. Rockwell's lead, late-stage investigational drug for iron therapy treatment is called SFP. SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. and $1B global market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval.
Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
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FDA Says to Cut Cefepime Dose in Patients with Kidney Disease - Renal Business Today |
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WASHINGTON—According to MedPage Today, the antibiotic cefepime (Maxipime) may cause a specific type of seizure in patients with kidney impairment when doses are not reduced appropriately, the U.S. Food and Drug Administration warned.
Nearly 60 cases of nonconvulsive status epilepticus have been reported to the FDA since cefepime was approved in 1996, the agency said in a drug safety communication.
In 58 of the 59 incidents, the patients had renal impairment, and, in 56, label recommendations for lowered doses were not followed. Most of the seizures occurred in patients older than 65.
Sixteen of the patients died, including two in whom the seizures might have contributed to the fatal outcome, according to the FDA. But the agency stopped short of concluding that failure to adjust cefepime dosages was a cause of any of the deaths.
The FDA has ordered that cefepime's label be revised to highlight the seizure risk in patients with renal impairment (those with creatinine clearance of ?60 mL/min) and reiterating the importance of dosage adjustments in such patients.
Clinicians with patients who have seizures while receiving cefepime should consider stopping the drug or reducing the dose in patients with renal impairment, the agency advised.
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