CRRT Business Switching Hands

Baxter to acquire Edward's CRRT business:

"Baxter International Inc announced a definitive agreement with Edwards Lifesciences Corporation under which Baxter will acquire certain assets related to Edwards’ hemofiltration product line, also known as Continuous Renal Replacement Therapy (CRRT). The transaction is expected to close in the third quarter of 2009, pending regulatory approvals.

Under the terms of the agreement, Baxter will provide Edwards an initial cash payment of approximately $56 million upon the close of the transaction. Additionally, Baxter will receive transition services from Edwards and is expected to pay Edwards up to an additional $9 million based on revenue objectives expected to be achieved over the next two years. The impact of this transaction is immaterial to Baxter’s financial results for 2009."

This makes sense, it fits in with Baxter's renal products, CRRT is a small market and the hardware and disposables are probably barely profitable especially with the low volumes Edwards was doing. Edwards never really gave it much attention. Presumably Baxter's solution operation is more profitable and soon they will work exclusively on what were previously Edward's Aquarius and other CRRT machines (Aquarius shown, image from the Aquarius Website).

Uremic Frost: "Fresenius and Prisma...it's your move."

Bedtime reading

The abstracts from the 2005 10th International Conference on Continuous Renal Replacement Therapies (CRRT), hosted by Dr. Mehta, are available online here.

Renal replacement therapy in the intensive care unit

Indian Journal of Critical Care Medicine has a great review article titled Renal replacement therapy in the intensive care unit by Jose Chacko. The article covers all the big hitters: IHD, CVVHD, CVVH, SCUF, and SLEDD. The most interesting part to me:

Continuous Vs Intermittent therapies - what's the evidence?

The physiological superiority of CRRT over conventional IHD is unquestioned. Does this result in improved clinical outcomes? Many trials that compare these modalities involve patients with different severity of illness at baseline; crossover from one arm to the other was also allowed in many studies, making it difficult to interpret the results. Besides, the majority of trials do not include patients with significant haemodynamic instability - precisely the subgroup of patients who are likely to have a survival advantage with continuous therapies. Kellum et al did a meta-analysis of 13 clinical trials involving 1400 patients. Out of this, only 3 were randomised. On unadjusted analysis, there was no difference survival between CRRT and IHD. However, when adjusted for study quality or baseline severity of illness, or both, CRRT was associated with improved survival. Under no conditions, either of inclusion criteria or adjustment method did CRRT fare worse. Mehta et al, in their study, randomised 166 patients to receive either IHD or CRRT. CRRT was associated with increased ICU and hospital mortality. However, patients in the CRRT group had a higher baseline severity of illness by APACHE II and III scores, more hepatic failure and more organ failures. There was strong bias in favour of IHD by all these counts, thus obviating meaningful analysis. In a more recent trial, Vinsonneau et al, for the haemodiafe group compared alternate day IHD with CRRT and reported no survival benefit at 60 days. However, the trial did not standardise the time of initiation of therapy or the dose of delivered dialysis. The actual CRRT dose delivered was only 25 ml/kg/hr, significantly less than the optimal 35 ml/kg/hr that has been associated with improved outcomes.

Chacko J. Renal replacement therapy in the intensive care unit. Indian J Crit Care Med 2008;12:174-80

Lins, et. al, Nephrology Dialysis Transplantation 2009 Study

Lins, et al, has a new study titled: Intermittent versus continuous renal replacement therapy for acute kidney injury patients admitted to the intensive care unit: results of a randomized clinical trial in Nephrology Dialysis Transplant.

The Nephrosphere criticizes it:

This study by Lins, et al. published in Nephrology Dialysis Transplanation addresses the age old question of whether continuous renal replacement therapy (CRRT) is superior to hemodialysis (HD) in acute kidney injury. The authors stratified by severity of illness and conclude that there’s no difference between the groups. In my mind, however, the fatal flaw is the people who were left out of the study. Out of the 650 subjects eligible and in need of RRT, over half (n=344) were excluded, 37% of them for clinical reasons (including coagulation distubrances and hemodynamic instability). In other words, the most unstable patietns, the ones most likely to benefit from CRRT, were excluded from the study! It’s hard to conclude much from this other than CRRT probably isn’t advantageous in more stable patients.

That comment gets right to the heart of the matter, CRRT is for the most unstable patients, ones where the regular hemodialysis is judged to be too much of a strain on the system. As noted above, a number of subjects were excluded for hemodynamic instability, but then the study says: "The main reason for conversion from IRRT to CRRT was haemodynamic instability" (and the other way for coagulation disturbances).

I highlight this point: "An overall mortality of 60.1% was observed." just so people with family members on CRRT in this condition are aware of the most likely outcome.

Looking closer at the outcomes, even though it didn't reach the 10% difference (or patient sample size for that matter) CRRT does coming out slightly "ahead": "Intention-to-treat analysis revealed a mortality of 62.5% in patients treated with IRRT compared to 58.1% in patients treated with CCRT (P = 0.430)." Along with this informative graphic:This is why we keep doing these studies, however, none of them can quite get to the definitive proof needed to claim that CRRT is better in certain patients. Lins, et al. does get closer than other recent attempts, and provides insight into the next steps he feels should be taken. There is certainly opportunity here for a researcher who finds the correct patient group to make a bit of a name for themselves.

The full study is currently available for free at the link.

CRRT Tutorials

CRRT Tutorials, an overview. In advantages, I'd quibble with:

Available 24 hours a day with minimal training.

Training should be pretty extensive!

Hat tip: Anaesthesia-Intensive care

CRRT post

Sinus arrhythmia has a post up on why she enjoys CRRT:

I loved doing CRRT while I was in the unit. Some ICU nurses love the ICU because of the adrenaline. I loved it for the multiple organ system failure, the very sickest of the sick. When we're still doin everything possible, and one system after another fails, dialysis becomes inevitable as do pressors. My unit's resource nurses knew I loved the 1:1 CRRT patients, so I got them often.

There is probably not very much adrenaline in CRRT, it just goes along and needs tweaking every now and then to keep running, but it is still technically challenging if you take the time to understand it and don't just let the machine run for the sake of running. There is a ton of information being collected and just waiting to be utilized in the best way possible.

CRRT patients are sick

Reality RN and talking RN both have items involving Continuous Renal Replacement Therapy (CRRT). While these examples are not centered on CRRT, it is important to illustrate just how serious the condition of people on CRRT usually is.

CRRT Pressures

Wake Forest Med Center has a note about pressures:

The Prisma measures pressures in several areas. It is very sensitive to changes in access pressures and return pressures. Therefore, if a patient is log rolled and the lines or catheter kink, the machine will stop and give an audible alarm. Most of the time this can be corrected by muting, identifying the problem and restarting the treatment.

This advice applies to every CRRT device (Prismaflex, Edwards, etc.) on the market, not just the Prisma, and presumably every dialysis system as well. Even a shift in position can change the pressure, moving the patient's bed up and down can increase or decrease the pressures. The access pressure alarm is most likely to be caused by patient position (lines or cather kinking, blocked, pinched, etc.), then the return pressure alarm. The effluent and filter pressure alarms are not directly influenced by patient position, but can trigger because of the access or return pressure being too high or low due to patient position.

While I believe change in position leading to pressure or kinking on the line or catheter is the most common cause of pressure alarms, additionally, the filter may be clotting, another line may be inadvertantly clamped (due to bag change or similar), or the access flow rate may be too high. More rarely a line could be leaking or the pressure transducer device or pod is failing or not calibrated correctly.

Depending on the pressure alarm, you may have to relieve the pressure by manually turning a pump backwards, consult the manual before doing so. It is important to note that while a pressure alarm is active, the blood pump is not moving, and clotting may occur in the tubing set or catheter if the problem is not fixed quickly (clotting can happen in as little as 5 minutes). Pressure alarms should be taken seriously and not ignored, every effort should be made to find and correct the problem before restarting the treatment, restarting blind and hoping the problem just goes away could lead to serious problems.

Nurse to Patient Ratio for CRRT

The nurse to patient ratio for a patient on continuous renal replacement therapy (CRRT) should be 1:1, don't let anyone tell you different. This is the ratio that I've seen the most, so hospitals are aware of the high demands CRRT patients and the device itself place on nursing. It is a complicated device and the patients require special attention, everything needs to be constantly monitored and updated. If your hospital's ratio is less than 1:1 then I would really look into it.