Clinical Voices November 2021

Nov 04, 2021

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This month we feature ethnic and racial factors of brain hemorrhage, data on pediatric DKA treatment and reducing stroke risk in patients with NVAF. Plus, read the new President’s Column and an enlightening Nurse Q&A.

Intracerebral Hemorrhage: Ethnic, Racial Factors

Addressing modifiable risk factors and the social determinants of health may reduce health disparities.

A 3,000-person study of intracerebral hemorrhage (ICH) finds that Black and Hispanic patients had earlier ICH onset than white patients and inadequate treatment of risk factors.

According to “Ethnic and Racial Variation in Intracerebral Hemorrhage Risk Factors and Risk Factor Burden,” in JAMA Network Open, the case-control study identifies sleep apnea as a novel risk factor for ICH. “The results suggest a strong contribution from inadequately treated hypertension and lack of health insurance to the disproportionate burden and earlier onset of ICH in Black and Hispanic populations.

“These findings emphasize the importance of addressing modifiable risk factors and the social determinants of health to reduce health disparities.”

The study examined 1,000 case participants in each group of Black, Hispanic and white patients with ICH along with 1,000 in each group for control, who were enrolled from 42 U.S. hospitals from 2009 to 2016.

The population attributable risk (PAR) percentages for treated and untreated hypertension were much higher for Black (53.6% and 45.5%, respectively) and Hispanic (46.5% and 42.7%) than for white patients (26.3% and 22.1%). “For both lobar and nonlobar ICH, history of ischemic stroke, chronic kidney disease, hypertension, low BMI, OSA [obstructive sleep apnea] risk, cocaine or amphetamine use, anticoagulant use, and lack of medical insurance were associated with increased risk, and moderate alcohol use was associated with decreased risk.”

PAR percentages for lack of medical insurance were 21.7% for Black patients, 30.2% for Hispanic patients and 5.8% for white patients. “Lack of medical insurance was associated with a similar degree of risk as cocaine, amphetamine, or anticoagulation use in each race/ethnic group but was associated with a much higher PAR percentage in Black and Hispanic participants,” the study adds.

Pediatric DKA: Sodium Changes Did Not Raise Brain Injury Risk

Thirteen urban U.S. emergency departments provided data for the trial.

Declines in glucose-corrected sodium concentrations among children receiving fluid treatment for diabetic ketoacidosis (DKA) did not increase the risk of cerebral injury or changes in mental status in a large, randomized trial.

Serum Sodium Concentration and Mental Status in Children With Diabetic Ketoacidosis,” in Pediatrics, also reveals that sodium concentration changes are affected mainly by the patient’s initial sodium values and the sodium content of infused fluids, not by the rate of infusion.

Thirteen urban U.S. emergency departments provided data as part of the “Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in Diabetic Ketoacidosis Trial.” Children ages 0-18 with DKA were randomly assigned to receive either 0.45% or 0.9% sodium chloride solutions infused at varying rates. Mental status was assessed using the Glasgow Coma Scale (GCS) and frequent short-term memory tests.

A related article in 2 Minute Medicine notes that factors resulting in glucose-corrected sodium declines included:

  • Older age
  • Higher initial sodium and chloride concentrations
  • Previous diabetes diagnosis
  • Treatment with 0.45% (vs. 0.9%) sodium chloride (NaCl) at all time points
  • Treatment with 0.9% NaCl at 12 hours
“GCS scores, memory function and cerebral injury did not vary significantly across groups,” the article adds.

In a video accompanying the study, co-author Nicole Glaser, UC Davis Health in Sacramento, California, says the findings provide “a little myth-busting” by revealing that “sodium is not as important as we once thought it was.

“It takes the pressure off clinicians in trying to keep the sodium in a narrow window and frees up time to concentrate on other important aspects of care,” Glaser notes, adding that the types of fluid administered impact sodium concentration, but the rate does not. “So, if you want to change the sodium, change the fluid type, but not the rate.”

Reducing Stroke Risk in Patients With NVAF

Overall, NOACs were better than warfarin to reduce risk of stroke, but major bleeding risk varied among NOACs.

Compared with warfarin, non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of stroke and systemic embolism for patients with nonvalvular atrial fibrillation (NVAF), but results varied for the risk of major bleeding events.

Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With High Risk of Gastrointestinal Bleeding,” in JAMA Network Open, finds that while the NOACs apixaban and dabigatran reduce major bleeding risks compared with warfarin, rivaroxaban may increase the risk. “The results may help inform decision-making regarding OACs in this high-risk population,” the study notes.

Involving more than 381,000 patients, the study is believed to be the largest to compare NOACs against warfarin among patients with NVAF and at least one of the following high-risk factors for gastrointestinal bleeding:

  • Age 75 or older
  • Impaired kidney function
  • Score of 3 or greater on HAS-BLED (hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age > 65, drug or alcohol use)
  • Concomitant use of NSAIDs, antiplatelet agents or corticosteroids
  • History of gastrointestinal ulcers or bleeds

A related article in 2 Minute Medicine notes that the unadjusted incidence of stroke and/or systemic embolism per 100 person years was 2.3 for patients receiving warfarin compared with 1.5, 1.7 and 1.6 for those prescribed apixaban, dabigatran and rivaroxaban, respectively. “Overall, NOACs were superior to warfarin in reducing stroke risk; however, the risk of MB [major bleeding] differed between NOACs,” the article adds.

The study is limited by its retrospective nature in that no causal relationships between oral anticoagulants and the desired outcomes could be examined. “Furthermore, although bleeding rates were documented, no lab data or bloodwork, such as international normalized ratio, was recorded to compare bleeding risk,” the article notes.

Beta-Blocker Therapy Dosage, Duration

New trials may help address improved guidelines on dosage, duration and patients’ selection for using beta-blockers post-MI.

An analysis of the benefits of beta-blocker therapy beyond one year after a myocardial infarction (MI) shows no general impact on survival with only one range of target doses showing enhanced benefit.

According to “One‐Year Landmark Analysis of the Effect of Beta‐Blocker Dose on Survival After Acute Myocardial Infarction,” in JAHA: Journal of the American Heart Association, “patients treated with >12.5% to 25% of the target dose used in prior randomized clinical trials beyond one year after MI may have enhanced survival compared with no beta‐blocker and other beta‐blocker doses.”

The analysis supports “the need for a new paradigm that addresses which patients should be treated, for how long, and at what dose. An important role for personalized medicine in the management of this diverse patient population must be incorporated.”

The analysis used the Outcomes of Beta-Blocker Therapy After Myocardial Infarction (OBTAIN) registry. Dosage data, which was available for 3,004 patients, was classified as no beta-blocker, > 0%-12.5%, > 12.5%-25%, > 25%-50% and > 50% of target dosage.

Several significant limitations, including that the analysis involved an observational cohort, impact the generalizability of these findings. The study cautions that “although the present findings are intriguing, they should be considered exploratory in nature.”

The clinical implications include a need for new trials to assess the standard guidelines for use of beta-blockers for at least three years and to test dosage. About 60% of patients from the OBTAIN registry remained on the same dosage one year after discharge, and almost 90% stayed on the therapy at any dosage despite some adverse effects that can diminish physical activity.

Immersive VR May Reduce Pediatric Pain

VR intervention is associated with decreased pain and anxiety for patients having painful procedures.

A study indicated a significant reduction in pain and anxiety for pediatric patients undergoing peripheral intravenous catheter (PIVC) placement if they use an immersive virtual reality (VR) system.

In “Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial,” in JAMA Network Open, a children’s hospital determined if a VR intervention was as effective in a randomized trial as small samples had indicated. “This study’s findings add to the evidence-based literature indicating that a VR intervention is capable of decreasing pain and anxiety among patients undergoing painful procedures.”

The single-site study in California included 107 patients ages 10-21, with 54 receiving standard care and 53 receiving immersive VR. Patients receiving VR had much lower anxiety scores and also much lower pain scores. Limitations include self-reported scores from the patients, caregivers and clinicians that could create bias, the small sample size and settings, and the study using only PIVC placement.

In a related article in Medical Xpress, lead study author Jeffrey Gold, The Saban Research Institute of Children’s Hospital Los Angeles, notes that reducing pain and anxiety can improve the experience for children and encourage adherence to ongoing treatments. The virtual game intervention permits patients to relax and often be less aware or unaware of procedures such as blood draws or PIVC placement.

“The mind is incredibly powerful at shifting focus and actually preventing pain from being registered,” Gold adds in the related article. “If we can tap into that, we can make the experience much better for our kids.”

Balanced Solution vs. Saline: Little Difference in 90-Day Survival

The findings do not support the use of a specific balanced solution.

For critically ill patients requiring fluid therapy, a specific balanced solution did not significantly improve 90-day survival compared with 0.9% saline solution.

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial,” in JAMA: The Journal of the American Medical Association, analyzes data involving 10,520 patients from May 29, 2017, to March 2, 2020, in 75 ICUs in Brazil. Eligible patients had at least one risk factor for acute kidney injury (AKI) and were expected to remain in the ICU for more than 24 hours.

By 90 days, 26.4% of 5,230 patients receiving intravenous treatment with the balanced solution died compared with 27.2% of 5,290 patients who received saline solution. “The findings do not support the use of this balanced solution,” the study notes, adding that “there were no unexpected treatment-related severe adverse events in either group.”

An accompanying editorial in JAMA notes that this study and similar ones over the last 20 years demonstrate no measurable risk for administering small to moderate amounts of 0.9% sodium chloride to critically ill patients at low risk for AKI. However, “debates continue surrounding the volume, composition, and rate of fluid administration, with few definitive answers to guide clinicians.”

The study lists several limitations that could impact outcomes, including some use of non-study fluids in small dilutions and fluid use in the operating room or emergency department prior to ICU stay. In addition, the study evaluates a specific balanced solution, noting that “it is unclear if other solutions with different buffers (such as lactate) would provide similar results.”

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