MORE CHOICE: The Kidney Society's new community dialysis house is giving renal patients more control over their treatment.

Hooking up is hard to do.

But a new community dialysis house in Mangere is making it easier for renal patient Keleni Ta'ala.

Dialysing for 20 hours every week leaves a lot of time for reflection, he says.

"I think about my wife and kids a lot and the sacrifices they make."

But being able to manage his own treatment in the privacy of Kidney Society Auckland's new community house has given the staunch Otahuhu Rugby League supporter some room in his restricted life.

"It's self management – the freedom to come in and do your treatment without being hindered."

The house has opened in partnership with Counties Manukau District Health Board renal service and gives 20 haemodialysis patients rostered days to dialyse on 10 machines.

Patients use the same room and machine for hygiene and continuity, Kidney Society executive director Nora van Der Schrieck says. And it's a more cost-effective option compared to hospital dialysis.

"The aim is to keep it as close to home dialysis as possible. It gives users the freedom they don't get at the hospital. Appointment times there are strict because of demand, making an even larger impact on people's lives."

Health Minister Tony Ryall officially opened the house last Thursday, cutting the ribbon with Mr Ta'ala. It's the society's second unstaffed community dialysis unit in Mangere.

"It's a massive sacrifice for the society to make sure that we have a place where we can better our health and our state of mind," Mr Ta'ala says.

"I like doing my treatment here. A lot of good people come here and it helps them be free.

"And it's non-judgmental."

With the unwavering support of his wife, Mr Ta'ala admits the hardest battle is the one inside.

"I've accepted that I am on a machine and that I am sick. But all along you're trying to fight it in the head that you're limited now.

"The journey is trying to stay employed now because it keeps my mind ticking over so I'm not just sitting at home vegetating, I'm actually being productive."

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Frailty is "exceptionally common" among kidney patients starting dialysis, researchers reported.

In a prospective observational study, 73% of patients starting dialysis met criteria for frailty, according to Yeran Bao, MD, of the University of California San Francisco, and colleagues.

And frailty was independently associated with the risks of both death and hospital admission, Bao and colleagues reported online in Archives of Internal Medicine.

Frailty was also associated with earlier initiation of dialysis, as indicated by a higher estimated glomerular filtration rate (eGFR) among frail patients compared with the non-frail minority, they found.

In recent years, Bao and colleagues noted, there has been a trend toward earlier initiation of dialysis: in 1996, less than 20% of patients started dialysis with an eGFR of 10 mL/min/1.73 m² or greater, while by 2009 the proportion was 54%.

And several studies have found that a higher eGFR when dialysis is started is associated with increased mortality, even in relatively healthy populations with few comorbidities, they noted.

But it has not been clear why physicians are starting patients on dialysis earlier, although one reason may be the high prevalence of frailty among those with end-stage renal disease, Bao and colleagues argued.

To help clarify the issue, they turned to the Comprehensive Dialysis Study, a U.S. cohort that enrolled patients starting dialysis from Sept. 1, 2005 to June 1, 2007. Participants were followed for vital status through Sept. 30, 2009, and for time to first inpatient admission through Dec. 31, 2008.

The goal of this analysis was to gauge the prevalence of frailty in the cohort and to test the notion that frailty was associated with earlier dialysis, Bao and colleagues reported.

Patients were defined as being frail if they reported any two of slowness/weakness, exhaustion, or low physical activity, as measured by the RAND12-item Short Form survey, the 36-item Kidney Disease Quality of Life symptoms/problems scale, and the Human Activity Profile, respectively.

Of the 1,576 patients analyzed, Bao and colleagues reported, 1,155 met their criteria for frailty. Even among those 40 or younger, the proportion of patients who were frail was 63%.

On average, frail patients had higher eGFR when they started dialysis than did non-frail participants -- 10.4 versus 8.8 mL/min/1.73 m² -- and the difference was significant at P<0.001.

In a multivariate analysis, Bao and colleagues found that higher eGFR was an independent predictor of frailty, with an odds ratio of 1.44 for each increment of 5 mL/min/1.73 m², which was significant at P<0.001.

All told, 522 participants (or 33%) died during a median follow-up of 2.9 years and, in unadjusted analysis, those who were frail at baseline had a nearly 80% increase in the risk of death, while those with a higher eGFR had a 24% increase in the risk of death for every increment of 5 mL/min/1.73 m².

In multivariate analysis, including such factors as age, demographics, comorbidities, and tobacco use, frailty remained independently associated with mortality and was also linked to time to first hospital admission, with hazard ratios of 1.57 and 1.26, both significant at P<0.001.

As well, higher eGFR was associated with mortality, with a hazard ratio of 1.12 for each increment of 5 mL/min/1.73m², which was significant at P=0.02.

However, when frailty was included in the model, the association was no longer statistically significant, the researchers reported, suggesting that the link between higher eGFR and mortality "may have been confounded by frailty."

Importantly, the researchers argued, the data did not show a benefit for early initiation of dialysis, regardless of whether patients were frail or not. The results "highlight the importance of considering factors other than eGFR to determine the timing of dialysis initiation."

As well, they argued that the data suggest that frailty "should not be considered" one of the clinical considerations or characteristic complications of kidney failure that guidelines state may prompt early initiation of therapy.

They cautioned that they calculated eGFR using the 4-variable Modification of Diet in Renal Disease (MDRD) study formula, which may have overestimated residual kidney function in patients with sarcopenia.

They also noted that they used a broad standard definition of frailty to allow comparison with other groups with chronic diseases, but a definition with more predictive power might be more useful in end-stage renal disease.

The study had support from the National Institute of Diabetes and Digestive and Kidney Diseases, the VA, the NIH, and the National Center for Research Resources.

Bao did not report any potential conflicts.

Primary source:Archives of Internal Medicine
Source reference:
Bao Y, et al "Frailty, dialysis initiation, and mortality in end-stage renal disease" Arch Intern Med 2012; 172: 1-7; DOI: 10.1001/archinternmed.2012.3020.

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Michael Smith

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North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers’ Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

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The number of patients needing dialysis after major elective surgery has tripled since 1995, a Canadian study suggests.

Severe acute kidney injury needing dialysis is a serious complication that is on the rise, harming survival and quality of life, researchers say in Monday's issue of the Canadian Medical Association Journal.

For the study, researchers reviewed data on 552, 672 patients in Ontario who had elective major surgery in the province between 1995 to 2009 to understand trends in dialysis. Of these patients, 2, 231 received acute dialysis within 14 days after surgery. The incidence increased from 0.2 percent in 1995 to 0.6 percent in 2009.

The surgeries included heart bypasses that didn't require emergency treatment, as well as other elective procedures like treating ballooning of the aorta — the major blood vessel supplying the legs — which may not cause symptoms but risks rupturing.

"We see the rates are going up but when someone develops this complication what is their prognosis?" asked kidney specialist Dr. Amit Garg of London Health Sciences Centre, one of the lead authors of the study.

"So unfortunately, when someone develops the complication and is sick enough after surgery to need dialysis, 40 per cent will unfortunately have died at 90 days. So it's a very high risk of death in patients who develop this complication. And in those who survive 90 days, one fourth are now left with permanent kidney failure needing ongoing maintenance dialysis and those outcomes haven't changed in the last 15 years."

For survivors who need dialysis long term, it can mean having to go for treatment three times a week.

Garg said the the paper aims to raise awareness of an important issue.

Older patients and weak kidneys

"It's serving as a call to action for us to work on testing strategies to prevent this from occurring and when it does occur, preventing people from having bad outcomes," he said.

Potential treatments being tested could include drugs and surgery, as well as changes to health services.

It's reasonable to assume that older, sicker patients may be higher risk of acute kidney injury, the researchers noted.

In particular, people who already had weak kidneys before the surgery were at highest risk, said Garg, who is also a professor of medicine and epidemiology at Western University, a scientist at ICES and a nephrologist at Lawson Health Research Institute.

Those with high blood pressure or diabetes were also at greater risk of suffering the kidney complication.

To conduct the study, Garg's team used three linked databases on hospital admissions and discharges, which included information on diagnoses and procedures performed as well a physician billing database and vital statistics.

"Worldwide, that means each year there's about a million people who require acute dialysis after major surgery," Garg said.

The researchers weren't able to tell if the thresholds for starting dialysis changed over the course of the study and the team did not have access to the patients' lab test results.

If someone had more than one admission to hospital during the study period then only the first one was analyzed to avoid selecting surgeries besides the first, elective one.

The other study authors were from Western, Toronto's Institute for Clinical Evaluative Sciences, University of Toronto, McMaster University in Hamilton and Yale University in New Haven, Conn.

The research was funded by the Lawson Health Research Institute.

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HOBOKEN, N.J., Jun 25, 2012 (BUSINESS WIRE) -- Octapharma USA today announced that it has started an initiative to make octagam(R) (immune globulin intravenous [human] 5%), a therapy for Primary Immune Deficiency, widely available to covered entities in the 340B Drug Pricing Program, which is managed by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA).

The 340B Drug Pricing Program is available to certain hospitals, clinics, and outpatient treatment facilities who qualify as "covered entities" under Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act.

"Octapharma is committed to providing therapies to treat life-threatening conditions to all patients, including those who are treated in facilities that have historically faced challenges accessing IGIV," said Octapharma USA President Flemming Nielsen. "We are pleased that the supply of octagam(R) 5% is now sufficient to adequately serve 340B covered entities, that have in recent years experienced difficulties in accessing specialty drugs such as IGIV at 340B discount prices. Octapharma is committed to serving patient needs, regardless of where they receive treatment, and ensuring a steady supply of octagam(R) 5% to all our hospital customers."

Octapharma USA intends to use ASD Healthcare of Frisco, Texas and FFF Enterprises of Temecula, Calif. as the contact point for distribution. More distributors will be added later in the year. Octapharma USA, a subsidiary of Octapharma AG, one of the world's largest human protein product manufacturers, has been marketing octagam(R) 5% since 2004.

Octapharma's commitment to making octagam(R) 5% available to 340B entities nationally will benefit those hospitals and medical facilities that face the constant challenge of obtaining adequate supplies of IGIV at the legally mandated discount rate. Over 17,000 covered entity sites participate in the 340B Program, including six categories of hospitals that are generally considered safety net providers, and 11 categories of non-hospital covered entities, such as federally qualified health centers and specialized clinics and treatment centers.

"Octapharma is extremely pleased to expand access to octagam 5% for 340B covered entities because the purpose of the national initiative is to maximize available healthcare resources and ensure that patient needs do not go unfulfilled," said Nielsen. "Octapharma's goal is to provide every patient the access to care they need. Providing patients with safe, high quality therapies is always our top priority."

WARNING: ACUTE RENAL DYSFUNCTION AND RENAL FAILURE

Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. octagam(R) (Human) 5% liquid does not contain sucrose.

IMPORTANT SAFETY INFORMATION

IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Epinephrine should be available immediately to treat any acute severe hypersensitivity reactions.

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Falsely elevated blood glucose readings may occur during and after the infusion of octagam(R) 5% liquid with some glucometer and test strip systems.

Hyperproteinemia, increased serum viscosity and hyponatremia occur in patients receiving IGIV therapy.

Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.

Aseptic Meningitis Syndrome has been reported with octagam(R) 5% liquid and other IGIV treatments, especially with high doses or rapid infusion.

Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. IGIV recipients should be monitored for pulmonary adverse reactions (TRALI).

The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Please review the complete octagam(R) (Human) 5% liquid prescribing information here or at http://www.octapharma.com/index.php?eID=tx_nawsecuredl&u=0&file=uploads/media/Octagam_5__SPC_for_USA_02.pdf&t=1340291554&hash=97c2fd6da6e8d4b170197e40603a881b8169eaa4 .

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma AG is one of the world's largest human protein products manufacturers and has been committed to patient care and medical innovation for nearly 30 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous. In the U.S., Octapharma markets octagam(R) (immune globulin intravenous [human] 5%) to treat primary immune deficiencies; Albumin (human)(R) for the restoration and maintenance of circulating blood volume; and wilate(R) (von Willebrand Factor/Coagulation Factor VIII Complex [human]), which has received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for certain types of von Willebrand Disease. Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com .

SOURCE: Octapharma USA

        
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