Introduction The optimal haemodialysis (HD) prescription—frequency and dose—for patients with incident dialysis-dependent kidney disease (DDKD) and substantial residual kidney function (RKF)—that is, renal urea clearance ≥2 mL/min/1.73 m 2 and urine volume ≥500 mL/day—is not known. The aim of the present study is to test the feasibility and safety of a simple, reliable prescription of incremental HD in patients with incident DDKD and RKF. Methods and analysis This parallel-group, open-label randomised pilot trial will enrol 50 patients from 14 outpatient dialysis units. Participants will be randomised (1:1) to receive twice-weekly HD with adjuvant pharmacological therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or outright thrice-weekly HD (standard HD group). Age ≥18 years, chronic kidney disease progressing to DDKD and urine output ≥500 mL/day are key inclusion criteria; patients with left ventricular ejection fraction <30% and acute kidney injury requiring dialysis will be excluded. Adjuvant pharmacological therapy (ie, effective diuretic regimen, patiromer and sodium bicarbonate) will complement twice-weekly HD. The primary feasibility end points are recruitment rate, adherence to the assigned HD regimen, adherence to serial timed urine collections and treatment contamination. Incidence rate of clinically significant volume overload and metabolic imbalances in the first 3 months after randomisation will be used to assess intervention safety. Ethics and dissemination The study has been reviewed and approved by the Institutional Review Board of Wake Forest School of Medicine in North Carolina, USA. Patient recruitment began on 14 June 2019, was paused between 13 March 2020 and 31 May 2020 due to COVID-19 pandemic, resumed on 01 June 2020 and will last until the required sample size has been attained. Participants will be followed in usual care fashion for a minimum of 6 months from last individual enrolled. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. Trial registration number NCT03740048 ; Pre-results.
Objective: Improving adherence to antihypertensive medications is the most significant modifiable patient related factor to achieving blood pressure (BP) control. Elevated BP remains the leading cause of death globally. BP trends show disparities in the burden of hypertension in black and low socioeconomic status (LSES) populations, accompanied by low levels of awareness, treatment and control rates. Telehealth systems using text messaging (SMS) and home blood pressure monitors (HBPM) represent attractive scalable tools to reduce BP in those with health disparities. Design and methods: In three ambulatory clinics that serve a large number of those with LSES affiliated with an academic institution, we conducted a randomized controlled pilot study for low medication adherent patients with poorly controlled hypertension (BP > 130/80). The pilot aimed to (1) evaluate the feasibility of recruiting LSES participants to an effectiveness trial of SMS plus HBPM vs HBPM only; (2) measure the acceptability of the SMS system and (3) estimate the effects of the SMS approach on lowering BP. Satisfaction was measured using the validated systems usability survey (SUS). The SMS system was designed with the input of LSES focus groups and used Twilio® as its bidirectional platform. From February 2021 to October 2021, 24 participants were randomized (1:1) to either SMS intervention plus HBPM with an Omron BP cuff or HBPM alone for 12 weeks. Results: During the study period, the study coordinator enrolled 24 participants, averaging 3 per month. Demographics: participants were male (N = 14/24), predominantly African American (AA); (n = 19/24); 13/24 had high school education or less; mean age 55.7 (SD 12); weight 97.4 kg (SD 14); Mean initial SBP 156 mmHg (SD 20), DPB 100 mmHg (SD 11). Acceptability: 8/12 participants responded via SMS with at least one BP measurement in the SMS arm. Two participants were lost to follow up in each arm. Mean SUS was 81.6 (scale of 0 to 100, > 68 is considered above average). Reduction in SBP at 12 weeks in the SMS group and control group was 15 mmHg and 13 mmHg respectively (p = 0.58). Conclusion: Recruiting and retaining LSES participants with uncontrolled HTN for a larger trial of telehealth with SMS and HBPM is feasible and well accepted. Similar BP reductions were achieved in both arms. Utilizing the SMS and HBPM shows promise in reducing BP in the LSES population. A larger efficacy trial is needed to determine best practice and reduce cardiovascular health disparities.
Hypertensive urgency (HU), defined as acute severe uncontrolled hypertension without end-organ damage, is a common condition. Despite its association with long-term morbidity and mortality, guidance regarding immediate management is sparse. Our objective was to summarize the evidence examining the effects of antihypertensive medications to treat. We searched the PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Cochrane Database of Systematic Reviews, Web of Science, Google Scholar, and Embase through May 2016. Study selection: We evaluated prospective controlled clinical trials, case–control studies, and cohort studies of HU in emergency room (ER) or clinic settings. We initially identified 11,223 published articles. We reviewed 10,748 titles and abstracts and identified 538 eligible articles. We assessed the full text for eligibility and included 31 articles written in English that were clinical trials or cohort studies and provided blood pressure data within 48 h of treatment. Studies were appraised for risk of bias using components recommended by the Cochrane Collaboration. The main outcome measured was blood pressure change with antihypertensive medications. Since studies were too diverse both clinically and methodologically to combine in a meta-analysis, tabular data and a narrative synthesis of studies are presented. We identified only 20 double-blind randomized controlled trials and 12 cohort studies, with 262 participants in prospective controlled trials. However, we could not pool the results of studies. In addition, comorbidities and their potential contribution to long-term treatment of these subjects were not adequately addressed in any of the reviewed studies. Longitudinal studies are still needed to determine how best to lower blood pressure in patients with HU. Longer-term management of individuals who have experienced HU continues to be an area requiring further study, especially as applicable to care from the generalist.
Background A decrease in blood pressure, even modestly (ie, 2 mmHg), lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. Preliminary studies have shown that SMS text messaging and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and blood pressure control. The best strategy to engage with older patients of low socioeconomic status who are low adopters of technology and disproportionally affected by uncontrolled hypertension is still unknown. Objective The objective of this study is to improve blood pressure control in the older, low socioeconomic status population. The study will test two aims: First, we aim to evaluate the feasibility of conducting a randomized controlled trial by using an SMS-based approach among nonadherent, older patients of low socioeconomic status who have uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome); patient acceptability will be evaluated by monitoring retention rates and SMS response rates and using the validated Systems Usability Scale (secondary outcomes). Second, we aim to estimate the effects of the SMS approach on lowering blood pressure and adherence to antihypertensive medications. Methods We will recruit 24 patients of low socioeconomic status with uncontrolled hypertension (systolic BP>140 mmHg or diastolic BP>90 mmHg) showing low medication adherence and taking at least two antihypertensives, who have presented to two outpatient clinics of Wake Forest Baptist Health (Winston Salem, North Carolina, USA). Participants will be randomly assigned to either SMS and HBPM (n=12) or usual care and HBPM (n=12) intervention. Clinicians adjusting the patients’ medications will be blinded to the study assignment. Text messages will be sent from a secure platform to assess medication adherence and HBPM on a weekly basis. The content and delivery frequency of the proposed SMS intervention are based on input from three focus groups conducted in Spring 2019. Participants in both study arms will receive education on HBPM and using an HBPM device. We hypothesize that we will successfully recruit 24 participants and the intervention will be acceptable to the participants. It will also improve medication adherence (assessed by question Medication Adherence Questionnaire scores) and blood pressure control. Results Our study was funded in July 2020. As of May 2021, we have enrolled 6 participants. Conclusions Our findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for older adults of low socioeconomic status. This study addresses a highly significant topic and targets a population of high morbidity and mortality that has been traditionally underrepresented in clinical trials. Trial Registration ClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242 International Registered Report Identifier (IRRID) PRR1-10.2196/18984
The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.
Objective
To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.
Design, Setting, and Participants
The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021.
Interventions
The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916).
Main Outcomes and Measures
The primary ordinal end point was organ support–free days (days alive and free of intensive care unit–based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned –1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support–free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support–free days; cardiovascular support–free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events.
Results
Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support–free days was 0 (IQR, –1 to 16) in the convalescent plasma group and 3 (IQR, –1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.
Conclusions and Relevance
Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support–free days.
'%3e%3cpath fill='%23012169' d='M0 0v30h60V0z'/%3e%3cpath stroke='%23fff' stroke-width='6' d='m0 0 60 30m0-30L0 30'/%3e%3cpath stroke='%23C8102E' stroke-width='4' d='m0 0 60 30m0-30L0 30' clip-path='url(%23b)'/%3e%3cpath stroke='%23fff' stroke-width='10' d='M30 0v30M0 15h60'/%3e%3cpath stroke='%23C8102E' stroke-width='6' d='M30 0v30M0 15h60'/%3e%3c/g%3e%3c/svg%3e)