Category: Uncategorized

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#DreamRCT late entry: FHN Do Over

Jason Prosek has submitted another DreamRCT. Jason is an assistant professor of nephrology at the Wexner Medical Center at the Ohio State University.  He is a general nephrologist with particular clinical interests in onco-nephrology and heart failure / ultrafiltration.  He is also heavily involved in fellow education.

Jason’s RCT is trying to actually put Tessin’s hemodialysis strategy to the test. It is an interesting trial and an ambitious idea. Check it out on Medium.

Jason can be found on Twitter.

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#DreamRCT Phase 2

For the past few weeks a few contributors have posted their personal ideas about the biggest

questions in nephrology. These ideas were presented in the form of proposed randomized controlled trials. Here is the cohort of #DreamRCTs so far:

I am grateful to each one of them that took up the call and contributed to this endeavor. For their time each one has received a DreamRCT mug or t-shirt.

I’m on the Dream Team #dreamRCT pic.twitter.com/Bh0wDI9KNP
— Pascale Lane (@PHLane) February 18, 2014

Dream it. Do it. My #DreamRCT in Nephrology, & hot tea from my new favorite mug! Thanks, Joel! @kidney_boy pic.twitter.com/c0n8VQp9LR
— ⓔⓓ ⓔⓛ ⓢⓐⓨⓔⓓ (@iApothecary) February 15, 2014

UKidney has collected all of the ideas and listed them together for the community to rank these ideas. But additionally, and importantly, they have provided a mechanism for everyone to contribute their own ideas for a DreamRCT. Go to the site, check it out and contribute. Nephrology is full of dark neglected corners that could use the bright light of a well conceived, randomized controlled trial.
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#DreamRCT: Prevent DeaDD

Swapnil Hiremath, a nephrologist from the great white north has taken up the call and has submitted the sixth #DreamRCT. I met Swapnil on Twitter where he is quite clever and insightful about nephrology research. Swapnil works in Ottawa, which is apparently Canada’s capital.

He writes, “In Ottawa, we are not fazed with the polar vortex – in fact our annual winter festival, the Winterlude is going on now.” He is a true citizen of the world who made it to Ottawa from Mumbai, where he trained at King Edward Memorial Hospital. After Mumbai he proceeded to Boston to pick up an MPH from Harvard. He is currently an Assistant Professor in the faculty of Medicine at the University of Ottawa. His turn-ons are epidemiological studies in acute kidney injury, resistant hypertension and vascular access. See his citations at Google Scholar.

His DreamRCT takes a swap at the high rate of CV death in dialysis patients by randomizing ICDs to them. Clever and important idea. I love that he didn’t dream small and took a shot at one of the most important issues in dialysis. His post is hosted at Medium. Read it here.

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#DreamRCT update: PHLane comes through

That was fast, moments after posting my plea for more entries, Pascale Lane posted her entry:

O My

Andin the grand tradition of big science, she already has the follow-up study planned before unrolling patient 1 in the first study. I can’t wait for NOMAD. Read it. Great work.

Her T-Shirt is in the mail.
You could be next.
Get’em done. Post’em up.

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#DreamRCT deadline approaches

We want to open the voting for the DreamRCT a week from tomorrow, but we are running into an obvious problem, we only have 4 entries which seems a little light:

  1. The Uric Acid causes CKD RCT that I did
  2. The Phosphate trial that Jordan did
  3. The IMAGINE trial by Paul Phelan at the Renal Fellow Network
  4. PHANTOM-1 trial of anticoagulation in ESRD by Ed El Sayed

Every nephrologist I know complains about the woeful state of evidence in nephrology, but in my mind if you can’t come up with a a DreamRCT, you have no legs to stand on.

Please write it up because if we don’t get it done Jordan has all kinds of Plan B’s that I don’t want to consider.

To sweeten the deal, we have DreamRCT t-shirts. The next six people to post their dream RCT will get a T-shirt complements of yours truly. Time to raid my wallet. Write your damn DreamRCT already.


What? You say you don’t have a blog to publish it? 
No problem, I’ll host it here at PBFluids. 

What? You say you would never post it to PBFluids, because Joel was once a dick on Twitter?
No problem, tweet at Jordan Weinstein (@UKidney) I’m sure you two can work something out, or go post it to Medium.

What? You say you have enough T-shirts?
No problem, I’ll send you a mug instead.


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#DreamRCT: Anticoagulation in Hemodialysis

Back in December, I had Ed El Sayed (@iApothecary) do the first guest post on PBFluids. He wrote about Nephron D for the top nephrology stories of the year project. It was one of my most popular stories of the fourth quarter of 2013. Ed is back with his contribution to the DreamRCT project:

When should dialysis patients with non-valvular Atrial Fibrillation be anti- coagulated?

Introduction

End Stage Renal Disease (ESRD) patients on dialysis have an increased risk for bleeding due to a number of factors, most notably failure of uremic platelets dysfunction (decreased degranulation and aggregation). This increases the risk of therapeutic anticoagulation in dialysis patients, they just have a significantly increased risk of bleeding.


Quantifying this risk is important because in numerous clinical situations the choice to anti coagulate or not to anti coagulate must ejudicated. Often times, clinicians are faced with an issue where the evidence base simply does not exist, or is unfortunately, ambiguous. When trying to determine if anticoagulation for atrial fibrillation is appropriate in ESRD patients, nephrologists, cardiologists, and pharmacologists cannot mine the medical literature for an answer. The evidence is insufficient.

That being said, experts recommend anti-coagulation pharmacotherapy in ESRD patients who have one or more of the following conditions: 
  • Pulmonary Embolism
  • Deep Vein Thromboembolism
  • Anti-Phospholipid Syndrome
  • Mechanical prosthetic cardiac valve

This expert recommendation is based on the hope that the anti-coagulation benefits in those conditions outweighs the risk of bleeding.

So where do we stand?

The Dialysis Outcomes And Practice Pattern Study (DOPPS) trial and the United Stats Renal Data Service (USRDS) both demonstrated an increasing rate of atrial fibrillation (AF) among dialysis patients. AF was also shown to be more prevalent in pre-dialysis CKD patients in the Chronic Renal Insufficiency Cohort (CIRC) trial. Even more worrisome is data showing that AF in ESRD patients increases all cause mortality. On the other hand, the data is inconsistent on the association between AF and stroke in ESRD patients (no association: here, and here, positive association: previous KI article).

Another dilemma clinicians often face in clinical practice is whether to use the CHAD2S2 score to assess the need for using warfarin to prevent stroke in AF patients on dialysis. While the CHAD2S2 score is a derivative of CHADS2 score, its validity was based on data from non-renal patients and experts advocate against using it on renal patents.
Several studies have been performed to determine the benefit of warfarin in AF patients on dialysis. The results however, were inconsistent. A few studies were pro-warfarin, while others were anti-warfarin.
Despite numerous studies, prospective data is both scant and contradictory. The data in patients without renal insufficiency, while compelling cannot be used to judge the safety and efficacy of anticoagulation in dialysis. This means we do not have the data to make the decisions we need.

My Dream RCT: The PHANTOM-1 Study

Placebo in Hemodialysis vs ANTicoagulation. My aim is to design a multi-center, randomized, double blinded, placebo controlled trial to study the effect of Warfarin pharmacotherapy in AF patients who require hemodialysis. PHANTOM-1 study would have the following criteria:

  • Inclusion Criteria
    • Age range 50 – 84 years
    • Sex males and females
    • CHADS2 Score greater than or equal to 2
    • History of Non-Valvular AF for 2 or more years
    • On Warfarin with INR 2-3
    • Ethnicity White, Asian, African American
    • History of ESRD requiring hemodialysis 3 or more times weekly
  • Exclusion Criteria
    • Age range younger than 50 years and older than 84 years
    • CHADS2 Score less than 2
    • AF secondary to valvular disease
    • History of Non-Valvular AF for less than 2 years
    • On Warfarin with INR below 2 or above 3
    • Renal disease without the need for hemodialysis
    • ESRD patients undergoing Peritoneal Dialysis
    • History of Neuro-endocrine disease

The study design would have 2 arms, with one group continuing to receive oral warfarin 5-10 mg once daily to maintain INR between 2-3, while the other group receive a placebo. The outcomes of the study would be as follows:

  • Primary Endpoint – Onset of Transient Ischemic Attack (TIA) or stroke (Ischemic or Hemorrhagic)
  • Secondary Endpoint – Incident of major bleeding (outside the CNS) and access survival.

All patients in the trial would receive multi-disciplinary medical counseling and monitoring throughout the study time frame. The result of the study would be welcomed and published, regardless of the outcome.


Prospectively studying this in a randomized, placebo controlled trial would definitively answer an increasingly common question that nephrologists, cardiologists and primary care doctors face.


Update 

I received this feedback:

As a long time hematologist with an interest in anticoagulation I was very interested by your post as this is something my nephrology colleagues and I discuss all the time. I would also advocate enrolling folks not currently on anticoagulation because even in the non-dialysis population a lot of patients with afib who should be on warfarin are not. The other issues is would renal dose adjusted new direct oral anticoagulants be safer (50% Risk reduction of ICH in trials) esp when the antidote become available.
if this program gets rolling let me know how I can help.
–tom Thomas DeLoughery, MD FACP FAWMInterim Associate Division HeadProfessor of Medicine, Pathology and PediatricsOregon Health & Sciences University

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The difference between treatment and prevention

The second twitter journal club a classic article by Rose, Strategy of prevention: lessons from cardiovascular disease. Br Med J 1981 282 pp. 1847-51.

My favorite line:

When ordinary doctors do not accept that responsibility then prevention is taken over (if at all) by uncritical propagandists, by cranks, and by battling commercial interests.

And this, on the treatment of hypertension:

A general practitioner, say, makes a routine measurement of a man’s blood pressure and finds it raised. There after both the man and the doctor will say that he “suffers” from high blood pressure. He walked in a healthy man but he walks out a patient, and his new-found status is confirmed by the giving and receiving of tablets. An inappropriate label has been accepted because both public and profession feel that if the man were not a patient the doctor would have no business treating him. In reality the care of the symptomless hypertensive person is preventive medicine, not therapeutics.

A systolic pressure of 160mm Hg may be common at these ages, but common does not mean good.

Remids me of this post from the archives.

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Fix Kidney Wikipedia #fikiWiki

Nephrology is a specialty in crisis. Fewer and fewer internal medicine residents are looking toward nephrology as a viable career. 

In 2011 there were 1.27 applicants for every nephrology fellowship position. In 2013 there were 0.76. http://t.co/3w6C7Cgd9j
— Joel Topf (@kidney_boy) January 9, 2014

The number of applicants continues to plummet. A number of people are looking at ways to increase interest. I’d like to point you to Mark Parker’s work with the ASN and Tejas Desai’s essay for F1000 (comments on the article). 
One of the solutions that people repeatedly return to is the need for better nephrology mentors for medical students and residents. I, like most people who ultimatly pursued nephrology can point to a great mentor. During my fourth year of medical school, I rotated with Dr Shermine Dabbagh, a pediatric nephrologist at children’s hospital of michigan. She was a great teacher and a caring clinician, but she was not my primary influence.
The chief inspiration was not a person at all, it was a book. During my fourth year of medical school, years before I was ready, I read Burton Rose’s classic, Clinical Physiology of Acid-Base and Electrolyte Disorders. It is a wonderful book and it absolutely was the inspiration that launched my career.
While the ASN is working on improving mentors, I think the influence of supportive texts like Rose’s should not be ignored. There are still great nephrology texts, but unfortunately students no longer use textbooks. They use the web and are increasingly depending on Wikipedia. Unfortunately the Kidney Wikipedia is pretty run down. It doesn’t give a reader the impression that the specialty is vibrant, well kept and alive.

Wikipedia is increasingly becoming the initial access point for people to learn about nephrology and we should be better caretakers of it as it is a reflection of our specialty.

I think a great way to revitalize student impression of nephrology is to fix the kidney Wikipedia.
FIx the KIdney WIKIpedia.
FiKiWiki.
Academics scoff at wikipedia, but it will be easier to fix wikipedia than it will be to get a generation of medstudents and residents to stop using it. It is time to stop fighting the Wikipedia and instead we should start refining it, fill it with compelling content that shows off nephrology as the exciting, important and a field that embraces the future of medical education. 
For more information on my opinions about wikipedia check out my editorial at Wing of Zock.

How I learned to stop fearing and love Wikipedia….my latest editorial at Wing of Zock. Go read it: http://t.co/ulIC823p30
— Joel Topf (@kidney_boy) January 23, 2014

@kidney_boy Nice article, biggest limitation is getting trainees to recognize errors? (especially subtly incorrect info)?
— DrWario (@DoctorWari0) January 23, 2014

@DoctorWari0 but isn’t that 1 of the most important lessons we should be treating students, how to recognize when source material is correct
— Joel Topf (@kidney_boy) January 24, 2014

@kidney_boy Loved your write up on @Wikipedia for @wingofzock potential exercise for #flippedlearning: use class time to edit wiki
— Rob Cooney, MD, MEd (@EMEducation) January 23, 2014

@kidney_boy @ShabbirHossain @krw127 We’re all “guilty”(?) of using wikipedia. knowing the limits of your sources is important. Thx for post!
— Charlie M. Wray (@WrayCharles) January 24, 2014

Yep. Also, Wikipedia is a good starting point MT @kidney_boy: How I learned to stop fearing and love Wikipedia…. http://t.co/OxXYzQUgRk
— Miloš Miljković (@Miljko) January 23, 2014

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Twitter, Nephrology and the next version of the KDIGOmobile App

This summer, through luck and/or moxie I was able to land a plum position on the KDIGO team charged with building the mobile app. The team partnered with the crazy effective nerds at Visible Health to push out our initial vision. Our 1.0 for iPad was launched at ASN Kidney Week in Atlanta. Internally, we described the project as building a bridge across a gorge. This 1.0 is like a piece of dental floss connecting the two sides. It is an important step but it we have big plans for future versions.

We have received a lot of feedback on the initial release and the overwhelming requests are: Android, iPhone, Android, iPhone, Android, iPhone.

We are going to do both, but neither are the next step. The 1.0 version is essentially a PDF reader with all 9 KDIGO guidelines pre-loaded. Moving the app to Android and the iPhone will entail porting all of the guidelines to a new data model. We have a big vision for the product and are reworking the infrastructure to get there. Those two updates will come but they need to wait for the new data structure, for now, the only thing I can tell you is: Patience.

The current version of KDIGO Mobile has a community option that is a ghost town. We are going to tear that down and instead adopt the renal community on Twitter. The new social section will have a number of ways to view twitter that are designed to expose new people to the vibrant nephrology discussions that occur in there.

Users will have a number of twitter channels that they can tune into:

  • Current Twitter users will be able to view their timeline
  • Collecting duct: this is a highly selected list of twitter accounts consisting primarily of professional societies, journals and government organizations (Members | Timeline)
  • Proximal tubule: this is a highly curated list of users that typically provide intelligent nephro-oriented discussion  (Members | Timeline)
  • Glomerulus: this is a general list of every nephrologist and nephrology related organization I could find. (Members | Timeline)
  • Hashtags: this will be one or two hashtags that are of interest to nephrologists. For example, during next years Kidney Week, we would push out #KidneyWk14, during NephMadness we would highlight #NephMadness, We might leave #MedEd, #FOAMed, and #HCSM up at other times. etc.

All of these channels are stored on the servers at Visible Health so they can be controlled remotely and are eternally updatable.

Today, we are asking members of the nephrology social media sphere to look at the lists, try out the timelines, explore the hashtags. Tell us if we missed anyone or added someone undeserving.

When evaluating the timelines keep in mind the goal of these Twitter channels. We want to introduce new users to the utility of twitter for nephrology discussions. The timeline that I am most concerned about is the proximal tubule. The collecting tubule is an official channel and will likely be pretty dry. The glomerulus I think will be too much of a fire hydrant and I am thinking about dropping that channel altogether. I’m hoping that the proximal tubule can have relevant, compelling, content to really show off the utility of Twitter to naive KDIGO users.

Any and all feedback would be appreciated.