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1. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia, adults

Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia, adults sodium zirconium cyclosilicate | CADTH.ca Find the information you need sodium zirconium cyclosilicate sodium zirconium cyclosilicate Last Updated: October 3, 2019 Result type: Reports Project Number: SR0612-000 Product Line: Generic Name: sodium zirconium cyclosilicate Brand Name: Lokelma Manufacturer: AstraZeneca Canada Inc. Indications: Hyperkalemia, adults Manufacturer Requested Reimbursement Criteria 1 : Corrective treatment (...) of hyperkalemia in adult patients (10 g administered three times per day, for 48 hours but up to 72 hours as needed), in line with the anticipated Health Canada approved indication. Maintenance treatment of hyperkalemia in adult CKD patients with an eGFR of Submission Type: New Project Status: Active Biosimilar: No Companion Diagnostics: No Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from

2019 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

3. How reliable are ECG findings in hyperkalemia?

How reliable are ECG findings in hyperkalemia? Chiefs’ Inquiry Corner – 10/14/19 – Clinical Correlations Search Chiefs’ Inquiry Corner – 10/14/19 October 14, 2019 2 min read The concentration and dose of epinephrine varies by indication. In 2016, the FDA banned the use of ratio expressions of epinephrine dosing, so clinicians should learn concentration-based dosing. An epinephrine auto-injector (aka EpiPen) contains the highest concentration of epinephrine at 1mg/mL. A dose of 0.3mg (0.3mL (...) prolongation, 24 had T-wave findings, and the majority were nonspecific. Additionally, the interobserver reliability was moderate. In a separate study of 170 patients with normal potassium levels and 135 patients with potassium >6 mmol/l, 24% of normokalemic patients and 46% of patients with elevated potassium levels had ECG findings suggestive of hyperkalemia. These studies suggest ECG findings should be used with careful consideration in the management of hyperkalemia. References: Patients with type 2

2019 Clinical Correlations

4. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/93250/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Lokelma International (...) with S-K levels between 3.5 and 4.5 mmol/L but, more importantly, S-K levels between 4.5 and 5.0 mmol/L, which is within the normal range, were associated with a 2-fold increased risk of mortality compared with S-K between 3.5 and 4.5 mmol/L. 2.1.2. Epidemiology Hyperkalemia develops when there is insufficient elimination, excessive intake, or shift of potassium from the intracellular space. Insufficient elimination, which is the most common cause of hyperkalaemia, can be hormonal (as in aldosterone

2018 European Medicines Agency - EPARs

5. Is Transcellular Potassium Shifting With Insulin, Albuterol, or Sodium Bicarbonate in Emergency Department Patients With Hyperkalemia Associated With Recurrent Hyperkalemia After Dialysis? (PubMed)

Is Transcellular Potassium Shifting With Insulin, Albuterol, or Sodium Bicarbonate in Emergency Department Patients With Hyperkalemia Associated With Recurrent Hyperkalemia After Dialysis? Emergency department (ED) treatment of hyperkalemia often involves shifting potassium into the intracellular space. There is uncertainty whether transcellular shifting causes insufficient potassium removal during hemodialysis, resulting in a subsequent need for further medical therapy or multiple sessions (...) of hemodialysis.We sought to determine whether transcellular potassium shifting in ED patients with hyperkalemia who undergo hemodialysis is associated with recurrent hyperkalemia with or without repeat hemodialysis within 24 h.This was a retrospective observational study of ED patients with a potassium value > 5.3 mmol/L and ≥1 hemodialysis run. Transcellular shifting medications were defined as albuterol, insulin, and sodium bicarbonate. Primary outcomes were recurrent hyperkalemia with and without repeat

2018 Journal of Emergency Medicine

6. A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia Patients with ESRD have minimal renal potassium excretion and, despite hemodialysis, often have persistent predialysis hyperkalemia. The DIALIZE study (NCT03303521) evaluated sodium zirconium cyclosilicate (SZC) in the management of hyperkalemia in hemodialysis patients.In the DIALIZE study, a double-blind, placebo-controlled, phase 3b (...) multicenter study, we randomized adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive placebo or SZC 5 g once daily on non-dialysis days, and titrated towards maintaining normokalemia over 4 weeks, in 5 g increments to a maximum of 15 g. The primary efficacy outcome was proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium of 4.0-5.0 mmol/L during at least three of four hemodialysis

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2019 EvidenceUpdates

7. Patiromer (Veltassa) - for the treatment of hyperkalemia in adults with chronic kidney disease

Patiromer (Veltassa) - for the treatment of hyperkalemia in adults with chronic kidney disease Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs

2019 Health Canada - Drug and Health Product Register

8. The blood sample is hemolyzed. Twice. Is there hyperkalemia on the ECG?

The blood sample is hemolyzed. Twice. Is there hyperkalemia on the ECG? Dr. Smith's ECG Blog: The blood sample is hemolyzed. Twice. Is there hyperkalemia on the ECG? Sunday, April 22, 2018 This patient presented from dialysis because his shunt was malfunctioning. He had no definite indication for dialysis unless his K was high. But every time we drew the K level, it was "hemolyzed." So we looked closely at his ECG for evidence of hyperkalemia. Is there evidence of hyperkalemia? Here is his (...) previous ECG when K is normal and all his medications were the same at that time. Are they different? The objective evidence of hyperkalemia on that top ECG is the prolonged PR interval . It is over 300 ms! (The PR in the previous is 218 ms) This prolonged AV conduction puts the patient at risk if his K were to rise further. Further, one might be tempted to blame a prolonged PR interval on vagal tone, especially at a slow heart rate of 60 beats per minute . But since the sinus rate in the old ECG

2018 Dr Smith's ECG Blog

9. Hyperkalemia and renin-angiotensin aldosterone system inhibitor therapy in chronic kidney disease: A general practice-based, observational study. (PubMed)

Hyperkalemia and renin-angiotensin aldosterone system inhibitor therapy in chronic kidney disease: A general practice-based, observational study. Data on hyperkalemia frequency among chronic kidney disease (CKD) patients receiving renin-angiotensin aldosterone system inhibitors (RAASis) and its impact on subsequent RAASi treatment are limited. This population-based cohort study sought to assess the incidence of clinically significant hyperkalemia among adult CKD patients who were prescribed (...) a RAASi and the proportion of patients with RAASi medication change after experiencing incident hyperkalemia. We conducted a retrospective, population-based cohort study (1 January 2013-30 June 2017) using Australian national general practice data from the NPS MedicineWise's MedicineInsight program. The study included adults aged ≥18 years who received ≥1 RAASi prescription during the study period and had CKD (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73m2). Study outcomes included

2019 PLoS ONE

10. Predictors for repeated hyperkalemia and potassium trajectories in high-risk patients - A population-based cohort study. (PubMed)

Predictors for repeated hyperkalemia and potassium trajectories in high-risk patients - A population-based cohort study. Understanding predictors and trajectories of increased potassium may inform testing and treatment of hyperkalemia. We examined predictors for repeated hyperkalemia among patients after first-time renin angiotensin system inhibitor (RASi) prescription, chronic kidney disease (CKD), or chronic heart failure (CHF); and we also examined potassium trajectories in these patients (...) after their first hyperkalemia event. We used Danish population-based registries to identify all patients with first-time RASi prescription, incident CKD, or incident CHF (2000-2012). For patients with a first hyperkalemia event, potassium trajectories over the following 6 months were examined. The predictors associated with repeated hyperkalemia were assessed, with repeated hyperkalemia defined as a potassium test >5.0 mmol/L after the first event within 6 months. Overall 262,375 first-time RASi

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2019 PLoS ONE

11. A Dialysis Patient With Hyperphosphatemia, Hyperkalemia, and Azotemia Without an Excessive Intake (PubMed)

A Dialysis Patient With Hyperphosphatemia, Hyperkalemia, and Azotemia Without an Excessive Intake 29142992 2019 02 26 2468-0249 2 4 2017 Jul Kidney international reports Kidney Int Rep A Dialysis Patient With Hyperphosphatemia, Hyperkalemia, and Azotemia Without an Excessive Intake. 770-773 10.1016/j.ekir.2017.02.006 Fukuoka Kazuhito K First Department of Internal Medicine, Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan. Sato Yuriko Y First Department

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2017 Kidney international reports

12. Treatment of Severe Hyperkalemia: Confronting 4 Fallacies (PubMed)

Treatment of Severe Hyperkalemia: Confronting 4 Fallacies Severe hyperkalemia is a medical emergency that can cause lethal arrhythmias. Successful management requires monitoring of the electrocardiogram and serum potassium concentrations, the prompt institution of therapies that work both synergistically and sequentially, and timely repeat dosing as necessary. It is of concern then that, based on questions about effectiveness and safety, many physicians no longer use 3 key modalities (...) in the treatment of severe hyperkalemia: sodium bicarbonate, sodium polystyrene sulfonate (Kayexalate [Concordia Pharmaceuticals Inc., Oakville, ON, Canada], SPS [CMP Pharma, Farmville, NC]), and hemodialysis with low potassium dialysate. After reviewing older reports and newer information, I believe that these exclusions are ill advised. In this article, I briefly discuss the treatment of severe hyperkalemia and detail why these modalities are safe and effective and merit inclusion in the treatment of severe

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2017 Kidney international reports

13. Treatment of Hyperkalemia With a Low-Dose Insulin Protocol Is Effective and Results in Reduced Hypoglycemia (PubMed)

Treatment of Hyperkalemia With a Low-Dose Insulin Protocol Is Effective and Results in Reduced Hypoglycemia Complications associated with insulin treatment for hyperkalemia are serious and common. We hypothesize that, in chronic kidney disease (CKD) and end-stage renal disease (ESRD), giving 5 units instead of 10 units of i.v. regular insulin may reduce the risk of causing hypoglycemia when treating hyperkalemia.A retrospective quality improvement study on hyperkalemia management (K+ ≥ 6 mEq (...) /l) from June 2013 through December 2013 was conducted at an urban emergency department center. Electronic medical records were reviewed, and data were extracted on presentation, management of hyperkalemia, incidence and timing of hypoglycemia, and whether treatment was ordered as a protocol through computerized physician order entry (CPOE). We evaluated whether an educational effort to encourage the use of a protocol through CPOE that suggests the use of 5 units might be beneficial for CKD/ESRD

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2017 Kidney international reports

14. The Cost of Hyperkalemia in the United States (PubMed)

The Cost of Hyperkalemia in the United States There are limited data on the cost of hyperkalemia.This retrospective analysis of the Truven MarketScan claims database assessed the economic burden of hyperkalemia among selected adult patients with hyperkalemia and matched controls.A total of 39,626 cases (patients with hyperkalemia) were matched to 39,626 controls (patients without hyperkalemia) based on age, dialysis, chronic kidney disease (CKD) stage, heart failure, and renin-angiotensin (...) ). When hospitalized, cases stayed 1.51 days (95% CI 1.22-1.80) longer and were 40% more likely to be readmitted.These data indicate that hyperkalemia is associated with a significant economic burden on afflicted patients and the health care system.

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2017 Kidney international reports

15. A curious case of persistently relapsing hyperkalemia in an ESRD patient on maintenance hemodialysis following bioprosthetic aortic valve replacement – a potential case for the use of the new agent, patiromer, for hyperkalemia management (PubMed)

A curious case of persistently relapsing hyperkalemia in an ESRD patient on maintenance hemodialysis following bioprosthetic aortic valve replacement – a potential case for the use of the new agent, patiromer, for hyperkalemia management Hyperkalemia is not uncommon in patients with end-stage renal disease (ESRD) on maintenance hemodialysis, often related to dietary indiscretion, following the prolonged inter-dialytic weekend interval in patients on thrice weekly hemodialysis treatments (...) , and sometimes the adverse effects of medications such as RAAS blocking agents. Moreover, hyperkalemia following extended cardiac surgery can result from the use of high-potassium containing cardioplegic solutions used during cardiopulmonary bypass. Nevertheless, different from the foregoing, in the nephrology literature, there have been very rare reports of potentially life-threatening hyperkalemia following cardiac valve replacement procedure. We recently encountered an unusual case of persistent relapsing

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2016 Journal of renal injury prevention

16. Perioperative hyperkalemia in hemodialysis patients undergoing parathyroidectomy for renal hyperparathyroidism. (PubMed)

Perioperative hyperkalemia in hemodialysis patients undergoing parathyroidectomy for renal hyperparathyroidism. The present study investigates the incidence of perioperative hyperkalemia and the influence factors of serum potassium levels during and after parathyroidectomy (PTX) in hemodialysis patients with renal hyperparathyroidism (rHPT). A total of 204 hemodialysis patients with refractory rHPT undergoing successful total parathyroidectomy with autotransplantation (tPTX + AT) were analyzed (...) retrospectively. Hyperkalemia was defined as serum potassium levels ≥ 5.5 mmol/L. The preoperative baseline level of serum potassium (K base+ ) was defined as a mean of the three preoperative prehemodialysis serum potassium levels. The higher levels of serum potassium during and immediately after surgery were recorded as K d0+ and the peak prehemodialysis serum potassium levels 3 days after surgery as K d3+ . 136/204 (66.7%) patients suffered from hyperkalemia during or immediately after surgery and 65/204

2019 Internal and emergency medicine

17. Sodium zirconium cyclosilicate (Lokelma) - To treat hyperkalemia

Sodium zirconium cyclosilicate (Lokelma) - To treat hyperkalemia Drug Approval Package: Lokelma (sodium zirconium cyclosilicate) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Lokelma (sodium zirconium cyclosilicate) Company: AstraZeneca Pharmaceuticals LP Application Number: 207078 Approval Date: 05/18/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter

2018 FDA - Drug Approval Package

18. Preventing Hypoglycemia Following Treatment of Hyperkalemia in Hospitalized Patients. (PubMed)

Preventing Hypoglycemia Following Treatment of Hyperkalemia in Hospitalized Patients. Hypoglycemia is a serious complication following treatment of hyperkalemia with intravenous insulin. The aims of this study were to determine the incidence of hypoglycemia (≤3.9 mmol/l, 70 mg/dL) and severe hypoglycemia (<3.0 mmol/l, 54 mg/dL) in noncritical care inpatients following treatment of hyperkalemia and to establish the risk factors predisposing to this complication. This was a single-center (...) observational study reviewing the Electronic Patient Records of hyperkalemia treatment with intravenous insulin on the general wards of a large UK teaching hospital. A total of 662 episodes of hyperkalemia treated with insulin/dextrose were included. Among these episodes, 116 treatments (17.5%) resulted in hypoglycemia and 47 (7.1%) resulted in severe hypoglycemia. Lower pretreatment capillary blood glucose level, older age, and lower bodyweight were associated with a higher risk of posttreatment

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2019 Journal of Hospital Medicine

19. New therapies for hyperkalemia. (PubMed)

New therapies for hyperkalemia. Although renin-angiotensin aldosterone system (RAAS) inhibitors have become the mainstay treatment for patients with chronic diseases, hyperkalemia is a major contributory deterrent to their use in patients with chronic kidney disease (CKD) and heart failure. For the first time in 50 years, two new therapies (patiromer and ZS-9) have recently emerged for the concomitant treatment of hyperkalemia in these patients. The objective of this review is to discuss (...) the efficacy and safety of these new agents.Patiromer effectively reduces serum potassium in patients with CKD and heart failure, even with the concomitant use of RAAS inhibitors. The most common adverse events in clinical trials were gastrointestinal events. ZS-9 (Lokelma) rapidly reduces serum potassium levels and to a greater magnitude, and has a role in the acute management of hyperkalemia. Despite having more adverse events than patiromer, ZS-9 is overall well tolerated.These new therapies show

2019 Current Opinion in Nephrology and Hypertension

20. Epidemiology and health outcomes associated with hyperkalemia in a primary care setting in England. (PubMed)

Epidemiology and health outcomes associated with hyperkalemia in a primary care setting in England. Real-world incidence, clinical consequences, and healthcare resource utilization (HRU) of hyperkalemia (HK) remain poorly characterized, particularly in patients with specific comorbidities.Data from the Clinical Practice Research Datalink and Hospital Episode Statistics databases were analyzed to determine incidence of an index HK event, subsequent clinical outcomes, and HRU in the English

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2019 BMC Nephrology

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