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Hurting Kidneys in Major Surgeries - dailyRx |
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Surgery can be a lifesaving measure for patients suffering from a number of diseases. Sometimes, though, surgery can lead to serious complications, including kidney damage.
The amount of patients who need dialysis after major elective surgery (e.g. heart surgery) has grown three-fold in the last couple decades.
This finding highlights the need for a better way to prevent kidney damage after these major elective surgeries.
Ask your doctor about possible complications before surgery.
Dialysis is a process that replaces the functions normally carried out by your kidneys. In both hemodialysis and peritoneal dialysis, the blood is filtered to rid the body of harmful wastes.
According to a recent study by Amit Garg, MD, of The University of Western Ontario, and colleagues, patients treated with acute dialysis after surgery continue to have poor outcomes.
"Our results should prompt renewed efforts to develop and test interventions to prevent severe acute kidney injury and to lessen the high burden of death and end-stage renal disease after acute kidney injury has occurred," says Dr. Garg.
These findings suggest that more needs to be done to prevent acute kidney injury, a severely harmful complication of major elective surgeries. When kidney damage cannot be prevented, more must be done to prevent total kidney failure and death caused by kidney damage.
Dr. Garg and colleagues studied more than 552,000 patients who underwent major elective surgeries such as heart and blood vessel surgery.
After surgery, 2,231 patients received acute dialysis. Of these, 937 died within three months of surgery. Of the surviving 1,294 dialysis patients, 352 needed long-term dialysis.
In 1995, about 0.2 percent of patients received acute dialysis after surgery. By 2009, that amount increased three times to 0.6 percent.
"The use of acute dialysis after [heart] and [blood vessel] surgery has increased substantially since 1995," says Nausheen F. Siddiqui, MD, also of Western University and lead author of the study.
Dr. Siddiqui concludes that there is a need for more research on ways to prevent and treat kidney injury after surgery.
The study is published in CMAJ.
Acute kidney failure occurs in about three to seven percent of the 37 million yearly admissions to United States hospitals, or about 1 to 2.6 million people. Acute kidney failure is a rapid loss of the ability of the kidneys to filter the blood and maintain the body's fluid and electrolyte balance.
It usually occurs in three settings: Loss of blood flow to the kidneys (blood loss, low blood pressure from heart failure, hardening of the renal arteries and blood clots), damage to the kidney tissue (from medications, infections, poisons), and obstruction of urine flow (enlarged prostate, urinary stones, bladder cancers, obstruction of the urethra). It is a medical emergency that can result in chronic kidney failure or death if left untreated.
Symptoms can be sudden, and are dependent on the type of kidney failure occurring. Usually, some combination of headache, fatigue, nausea, and loss of appetite is common. Irregular heartbeat, blood in the urine, seizures, swelling of the feet, and pain in the flanks may also occur.
Diagnosis is made by testing the blood chemistry, and sometimes ultrasound and CT scan. Treatment is aimed at eliminating the underlying cause of kidney failure, for example, in fluid loss, restoring fluids and electrolytes; in injury, removing the offending drug; in blockage, removing the blockage.
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Argos Therapeutics Receives FDA Approval of Special Protocol Assessment for ... - MarketWatch (press release) |
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DURHAM, N.C., Jul 2, 2012 (GlobeNewswire via COMTEX) -- Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis(TM) technology platform, today announced the U.S. Food & Drug Administration (FDA) has approved the Company's revised Special Protocol Assessment (SPA) for its Phase 3 clinical study of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC). The Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) study has initiated and is expected to begin dosing patients in the second half of 2012, with a primary clinical endpoint of overall survival.
"FDA acceptance of our revised SPA is an important step forward for our continued clinical development of AGS-003 in newly diagnosed mRCC patients," said Jeff Abbey, Chief Executive Officer of Argos Therapeutics. "Based on the highly encouraging long-term survival we observed in our Phase 2 combination study of AGS-003 plus sunitinib, we amended our Phase 3 protocol to focus on a primary endpoint of improving overall survival for patients randomized to receive AGS-003 plus sunitinib versus sunitinib alone. With our revised SPA, the FDA has agreed that the pivotal ADAPT study could support a future BLA submission if the study objectives are met."
In a Phase 2 study, treatment with AGS-003 was associated with encouraging median and long-term survival for newly diagnosed mRCC patients who presented with intermediate or poor risk ("unfavorable" risk) factors. Adding AGS-003 to standard sunitinib doubled overall survival for these patients compared to historical results1 for unfavorable risk patients treated with sunitinib alone. Importantly, greater than 50 percent of patients in the study survived longer than 30 months after initiating therapy, which is four times the expected rate for sunitinib2, suggesting a pronounced survival benefit for the combination regimen with no added toxicity.
"The key to AGS-003's encouraging clinical benefit and lack of toxicity is its remarkable specificity for the tumor," stated Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics. "Other immunotherapies use non-mutated self antigens, which are poorly immunogenic and are usually paired with non-specific immune stimulators, or adjuvants. AGS-003 is a fully personalized active immunotherapy that preferentially targets mutated tumor antigens known to drive progression of disease. These mutated antigens are recognized as foreign by T-cells in the body, which allows AGS-003 to direct a potent and highly specific immune response against the tumor, with no collateral damage to healthy tissues."
Dr. Nicolette continued, "In our phase 2 combination study, we demonstrated a statistically significant correlation between the number of anti-tumor T-cells induced and overall survival in mRCC patients receiving AGS-003. This strong correlation validates our mechanism of action and gives us confidence to advance AGS-003 into the pivotal ADAPT study with a primary objective of improving overall survival."
The ADAPT Phase 3 study is a 2:1 randomized, multicenter, open-label study of AGS-003 in combination with standard targeted therapy, beginning with sunitinib, compared to targeted therapy alone in newly diagnosed mRCC patients. A total of 450 patients will be enrolled at approximately 100 sites in North America and ex-U.S. The study design is similar to the previous Phase 2 combination study, but with key differences that Argos believes will ensure clinical success and that are addressed in the revised SPA. The study's primary endpoint is overall survival (OS). Additional endpoints will include overall response, immune response, progression-free survival (PFS) and safety.
About Special Protocol Assessments (SPA)
A Special Protocol Assessment is a written agreement with the FDA on the details of the design and planned analysis for a clinical trial. It is intended to form the basis for a marketing application and may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new public health concerns.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer accounting for nearly 90% of newly diagnosed cases each year. Overall, 15-20% of kidney cancer patients are diagnosed with the metastasized form of the disease, referred to as mRCC. Taking into account both newly diagnosed mRCC and early stage RCC patients who advance to mRCC, there are an estimated 25,000 cases of mRCC in the U.S. each year. Patients are classified at the time of diagnosis into three disease risk profiles--favorable, intermediate and poor--using objective prognostic risk factors. Prognosis is generally poor for those with newly diagnosed mRCC and one or more risk factors (intermediate and poor risk), where expected survival is only 6 months to less than two years.
About the Arcelis(TM) Technology
Arcelis is a fully personalized, active immunotherapy technology that captures all antigens, including mutated and variant antigens that are specific to each patient's disease. It has been shown to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that are associated with toxicity. The technology can be leveraged to manufacture personalized therapies for any cancer or infectious disease.
The Arcelis process integrates readily into many current treatment paradigms, using only a small tumor or blood sample and the patient's own dendritic cells, which are derived and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient sample to program the dendritic cells to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered as an injection into the skin to produce the desired patient-specific immune response.
Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other cancer immunotherapies. Automated processes allow a single facility to serve all of North America and can be used to treat any cancer or infectious disease with the same manufacturing process and equipment.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis(TM) technology platform. Argos' most advanced product candidate AGS-003 has initiated a Phase 3 study for the treatment of mRCC, and the Company plans to have data from its Phase 2b study of AGS-004 for the treatment of HIV in the second half of 2013. Argos also recently completed a successful Phase 1a study of AGS-009 in patients with lupus.
1 Heng et al. International mRCC Consortium Database. November 2011.
2 Motzer et al. 10th International Kidney Cancer Symposium. October 14, 2011. Poster presentation.
This news release was distributed by GlobeNewswire,
www.globenewswire.com
SOURCE: Argos Therapeutics
CONTACT: The Ruth Group
Victoria Aguiar (media)
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
(646) 536-7013
Joshua Drumm (investors)
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(646) 536-7006
Argos Therapeutics
Jeff Abbey
(919) 287-6308
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.
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Death by chocolate: Little Lola can't eat chocolate because it might kill her - Mirror.co.uk |
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A little girl can't eat CHOCOLATE because it might kill her.
Lola Raine, five, suffers from a rare kidney and liver disease which means even a small piece could POISON her.
Just a mouthful of creamy chocolate would cause her potasium levels to rise, potentially poisoning her body and leaving her in a critical condition.
Her worried parents discovered she had Autosomal Recessive Polycystic Kidney Disease - ARPKD - before she was even born - and were told she would need a liver and kidney transplant.
And in a cruel twist of fate, little Lola lives less than 10 miles from the Cadbury factory in Birmingham, West Mids.
Mum Natalie, 35, said: "If Lola ate any chocolate it would be life-threatening.
"She does ask for it but she gets really upset and cries as she can't have it. She gets jealous when she sees her friends eating it.
"Her kidneys can't remove waste properly, so things like potassium build up in the blood and damage her body.
"It means she can't eat chocolate, chips, cereals and crisps. I tend not to bring them into the house.
"She's basically on a diet of sausages, toast and plain pasta until her transplant as that's the safest food to eat.
"I have to be really careful what I bring into the house because if Lola sees those things she wants them.
"She's on the waiting list for a transplant but she's had two cancelled already. It would be a life-saving operation.
"Her condition has got worse. She has end-stage renal failure, it it gets worse she could need dialysis.
"She's always in hospital but she's very resilient. She has to go to the hospital every three months for a check-up.
"When I discovered Lola had it - just like her sister Nicole - I thought 'Oh no, not again'. I was in tears, it was awful. But her sister is now doing
really well and that's our hope for Lola."
Her dad, Tim, 46, who works for British gas said: "It's really heartbreaking. It's harder for her because others can eat it. We can't even go away on holiday because we need to be 15 minutes away from the hospital.
"I don't eat chocolate in the house but might sneak some at work."
Her sister Nicole, 10, also suffered from ARPKD but after a combined liver and kidney transplant she can now eat as much chocolate as she likes.
Other siblings Taylor, 8, Molly, 6, and Laice, 3, can all eat chocolate and crisps.
Tess Harris, chairman of Polycystic Kidney Disease Charity, said: "It's a rare inherited condition, inherited from parents who are carriers.
"It can be fatal before and after birth. It can be life threatening unless you get a kidney transplant or have dialysis.
"Sufferers of it feel unwell, have tiredness. Anaemia is also a big problem and very high blood pressure can bring risk of heart disease and a stroke.
"They may also need dialysis treatment as the kidneys stop doing its job removing toxins from the blood."
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Ultra-Low CT Dose Accurately Detects Renal Stones - Renal and Urology News |
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BANFF, Alberta—Ultra-low-dose computed tomography (CT) can accurately discriminate between true cases of renal colic and pathologies with symptoms due to other causes, according to a study presented at the Canadian Urological Association (CUA) annual meeting.
In a prospective study of 56 patients with suspected renal colic, ultra-low-dose CT had a sensitivity of 92% and a specificity of 100% for detecting renal stones. The sensitivity increased to more than 97% when the stones were larger than 2 mm in diameter.
“Once we publish a manuscript on our results, our plan is to come up with guidelines between urology, radiology and emergency medicine for the use of the ultra-low-dose protocol,” said Iain Kirkpatrick, MD, Associate Professor of Diagnostic Radiology at the University of Manitoba in Winnipeg and Adjunct Clinical Instructor in diagnostic radiology at Stanford University in Palo Alto, Calif. “We would want to target it at patients who have a high pretest probability of calculi and obstructive uropathy, since the ability to detect other pathology is hindered. For now, we are still performing them under the study protocol.”
The American Urological Association and the European Association of Urology have both adopted recommendations for the use of low-dose CT for renal colic. The new study takes this a step further by focusing on ultra-low-dose CT, which gives a radiation dose of just 20 mA. This translates into a greater than 95% reduction in radiation dose compared with standard CT when the length of the scans is taken into consideration.
Jason Archambault, MD, a senior urology resident at the University of Manitoba, led the study under Dr. Kirkpatrick's supervision. The study began in November 2010 and is ongoing. The analysis presented at the CUA meeting included 56 emergency-department patients with suspected renal colic who underwent a standard CT of the kidneys, ureters, and bladder. An ultra-low-dose CT scan was also performed on each patient, taking less than one additional minute. The two sets of CTs from each patient were each interpreted by four blinded radiologists.
The subjects had a mean age of 58 years and a mean body mass index (BMI) of 29 kg/m2.
Thirty-six of the patients were found on standard CT to have an obstructing stone and 33 of these were also found to have a stone on ultra-low-dose CT. There were no false positives with the ultra-low-dose approach. There was a high inter-observer agreement between the four radiologists who read the CT scans. This included a high level of agreement about the presence of hydronephrosis, which was a secondary outcome measure.
The average size of the stones in patients with false negatives—that is, in whom ultra-low-dose CT did not show a stone—was 2.4 mm. In comparison, the true positives' average stone size was 3.8 mm. There was not a significant difference in BMI between the true-positive and false-negative groups.
The investigators found that image quality was worse in high-BMI patients, but the study was not large enough to show a statistically significant difference.
“We did not find that there was a significant difference in diagnostic utility of the scan by BMI, but again this could be because of the low patient numbers,” Dr. Kirkpatrick noted. “Once all the data are in we may end up recommending a modified protocol for high-BMI patients, but this is still to be worked out.”
The radiologists had an average 75% rating of being ‘very confident' in diagnosis with standard CT and an average 48% rating of this level of confidence with ultra-low-dose CT.
“One of the things we intend to look at is whether tests interpreted at the end of the study tend to be read with more confidence than those at the beginning,” Dr. Kirkpatrick said. “The relatively low observer confidence with ultra-low-dose CT that we found overall does not reflect low enthusiasm at all for the protocol. The idea for the ultra-low dose exams was a joint one between urology and radiology, who have an excellent working relationship in Winnipeg.”
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