Resistant Hypertension Optimal Treatment Trial: A Randomized Controlled Trial

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin‐converting enzyme inhibitors or angiotensin‐receptor blockers, and calcium channel blockers are largely used as the first 3‐drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin‐angiotensin‐aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study ( ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3‐month treatment with spironolactone (titrating dose, 12.5–50 mg once daily) or clonidine (titrating dose, 0.1–0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12‐week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3‐drug standard regimen.     

Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial

For patients exposed to a massive blood loss during surgery, maintained coagulation competence is important. It is less obvious whether coagulation competence influences bleeding during elective surgery where patients are exposed to infusion of a crystalloid or a colloid.This randomized controlled trial evaluates whether administration of 5% human albumin (HA) or lactated Ringer solution (LR) affects coagulation competence and in turn blood loss during cystectomy due to bladder cancer.Forty patients undergoing radical cystectomy were included to receive either 5% HA (n = 20) or LR (n = 20). Nineteen patients were analyzed in the HA group and 20 patients in the lactated Ringer group.Blinded determination of the blood loss was similar in the 2 groups of patients: 1658 (800–3300) mL with the use of HA and 1472 (700–4330) mL in the lactated Ringer group (P = 0.45). Yet, by thrombelastography (TEG) evaluated coagulation competence, albumin affected clot growth (TEG-angle 69 ± 5 vs 74° ± 3°, P < 0.01) and strength (TEG-MA: 59 ± 6 vs 67 ± 6 mm, P < 0.001) more than LR. Furthermore, by multivariate linear regression analyses reduced TEG-MA was independently associated with the blood loss (P = 0.042) while administration of albumin was related to the changes in TEG-MA (P = 0.029), aPPT (P < 0.022), and INR (P < 0.033).This randomized controlled trial demonstrates that administration of HA does not affect the blood loss as compared to infusion of LR. Also the use of HA did not affect the need for blood transfusion, the incidence of postoperative complications, or the hospital in-stay. Yet, albumin decreases coagulation competence during major surgery and the blood loss is related to TEG-MA rather than to plasma coagulation variables.     

Comparison Between Digital and Manual Marking for Toric Intraocular Lenses: A Randomized Trial

To compare the clinical outcome of digital and manual marking for toric intraocular lens (IOL) alignment.This is a prospective clinical study that included 60 eyes of 60 patients undergoing cataract surgery with coexisting corneal astigmatism more than 1 diopter (D). The eyes were randomly assigned to either digital image guidance using VERION digital marker (Alcon Laboratories, Ft. Worth, TX) or manual slitlamp-assisted preoperative marking using pendulum-attached marker. Tecnis toric IOL (Abbott Medical Optics, Inc, Santa Ana, CA) was implanted in all cases.The mean postoperative uncorrected distance visual acuity (UCDVA) for the digital-marking group was 0.12 + 0.12 logMAR, and for the manual-marking group was 0.18 + 0.14 logMAR (P = 0.104). The mean deviation from targeted induced astigmatism (TIA) for the first group was 0.10 + 0.08 D and for the second group was 0.20 + 0.14 D (P = 0.001). The mean postoperative toric IOL misalignment measured by the slitlamp was 2.4° + 1.96° for the first group and was 4.33° + 2.72° for the second group (P = 0.003).Accurate alignment of the toric IOL is important to achieve the desired astigmatism correction. VERION system has the advantage of preoperative planning and intraoperative digital guidance of the toric IOL alignment. The use of VERION system resulted in less postoperative deviation from TIA and showed less postoperative toric IOL misalignment than using manual-marking technique.     

Effects of Hypothermic Cardiopulmonary Bypass on Internal Jugular Bulb Venous Oxygen Saturation,Cerebral Oxygen Saturation,and Bispectral Index in Pediatric Patients Undergoing Cardiac Surgery: A Prospective Study

The objective of this study was to evaluate the effect of hypothermic cardiopulmonary bypass (CPB) on cerebral oxygen saturation (rSO2), internal jugular bulb venous oxygen saturation (SjvO2), mixed venous oxygen saturation (SvO2), and bispectral index (BIS) used to monitor cerebral oxygen balance in pediatric patients.Sixty American Society of Anesthesiologists Class II-III patients aged 1 to 4 years old with congenital heart disease scheduled for elective cardiac surgery were included in this study. Temperature, BIS, rSO₂, mean arterial pressure, central venous pressure, cerebral perfusion pressure (CPP), and hematocrit were recorded. Internal jugular bulb venous oxygen saturation and SvO₂ were obtained from blood gas analysis at the time points: after induction of anesthesia (T0), beginning of CPB (T1), ascending aortic occlusion (T2), 20 minutes after initiating CPB (T3), coronary reperfusion (T4), separation from CPB (T5), and at the end of operation (T6). The effect of hypothermia or changes in CPP on rSO₂, SjvO₂, SvO₂, and BIS were analyzed.Compared with postinduction baseline values, rSO₂ significantly decreased at all-time points: onset of extracorporeal circulation, ascending aortic occlusion, 20 minutes after CPB initiation, coronary reperfusion, and separation from CPB (P < 0.05). Compared with measurements made following induction of anesthesia, SjvO₂ significantly increased with initiation of CPB, ascending aortic occlusion, 20 minutes after initiating CPB, coronary reperfusion, and separation from CPB (P < 0.05). Compared with induction of anesthesia, BIS significantly decreased with the onset of CPB, aortic cross clamping, 20 minutes after initiating CPB, and coronary reperfusion (P < 0.05). Bispectral index increased following separation from CPB. There was no significant change in SvO₂ during cardiopulmonary bypass (P > 0.05). Correlation analysis demonstrated that rSO₂ was positively related to CPP (r = 0.687, P = 0.000), with a low linear correlation to temperature (r = 0.453, P = 0.000). Internal jugular bulb venous oxygen saturation was negatively related to temperature (r = −0.689, P = 0.000). Bispectral index was positively related to both temperature (r = 0.824, P = 0.000) and CPP (r = 0.782, P = 0.000). Cerebral oxygen saturation had a positive linear correlation with CPP and a low linear correlation to temperature. Internal jugular bulb venous oxygen saturation had a negative linear correlation to temperature.Pre-and and early postbypass periods are vulnerable times for adequate cerebral oxygenation. Anesthetic management must aim to optimize the supply and demand relationship.     

Levocarnitine Decreases Intradialytic Hypotension Episodes: A Randomized Controlled Trial

Intradialytic hypotension is common complication in stage 5 chronic kidney disease patients on hemodialysis. Incidence ranges from 15 to 30%. These patients have levocarnitine deficiency. A randomized, placebo‐controlled quadruple‐blinded trial was designed to demonstrate the levocarnitine efficiency on intradialytic hypotension prevention. Patients were randomized into four groups, to receive levocarnitine or placebo. During the intervention period, levocarnitine and placebo was administered 0 and 30 min before each hemodialysis session, respectively. During the trial, 33 patients received 1188 hemodialysis sessions. We identified 239 (21.3%) intradialytic hypotension episodes. The intradialytic hypotension episodes were less frequent in the levocarnitine group (9.3%, 60 IH events) (P < 0.001). Hemodialysis is frequently perplexed by intradialytic hypotension episodes. Levocarnitine supplementation before each hemodialysis session efficiently diminishes the intradialytic hypotension episodes. This is a new application method that must be considered and explored.     

Mindfulness-Based Stress Reduction for Residents: A Randomized Controlled Trial

Background

Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents.

Objective

To determine the effectiveness of MBSR in reducing burnout in residents.

Design

A randomized controlled trial comparing MBSR with a waitlist control group.

Participants

Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred.

Intervention

The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day.

Main Measures

The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory–Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work–home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later.

Key Results

Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p?=?0.028, d?=?0.24), worry (p?=?0.036, d?=?0.23), mindfulness skills (p?=?0.010, d?=?0.33), self-compassion (p?=?0.010, d?=?0.35) and perspective-taking (empathy) (p?=?0.025, d?=?0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit.

Conclusions

The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.

     

Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on the Quality of Postoperative Analgesia in Highly Nicotine-Dependent Patients After Thoracic Surgery: A CONSORT-Prospective,Randomized, Controlled Trial

Smoking is one of the most common addictions in the world. Nicotine inhalation could increase the risk of cardiorespiratory diseases. However, the solution that improved postoperative analgesia for highly nicotine-dependent patients undergoing thoracic surgery has not been specifically addressed.This CONSORT-prospective, randomized, double-blinded, controlled trial investigated the efficacy of combination of dexmedetomidine and sufentanil for highly nicotine (Fagerstrom test of nicotine dependence ≥6)-dependent patients after thoracic surgery.One hundred seventy-four male patients who underwent thoracic surgery were screened between February 2014 and November 2014, and a total of forty-nine were excluded. One hundred thirty-two highly nicotine-dependent male patients who underwent thoracic surgery and received postoperative patient-controlled intravenous analgesia were divided into 3 groups after surgery in this double-blind, randomized study: sufentanil (0.02 μg/kg/h, Group S), sufentanil plus dexmedetomidine (0.02 μg/kg/h each, Group D1), or sufentanil (0.02 μg/kg/h) plus dexmedetomidine (0.04 μg/kg/h) (Group D2). The patient-controlled analgesia (PCA) program was programmed to deliver a bolus dose of 2 ml, with background infusion of 2 ml/h and a lockout of 5 min, 4-hour limit of 40 ml, as our retrospective study. The primary outcome measure was the cumulative amount of self-administered sufentanil; the secondary outcome measures were pain intensity (numerical rating scale, NRS), level of sedation (LOS), Bruggrmann comfort scale (BCS), functional activity score (FAS), and concerning adverse effects.The amount of self-administered sufentanil were lower in group D2 compared with S and D1 groups during the 72 hours after surgery (P < 0.05), whereas the total dosage and dosage per body weight of sufentanil were significantly lower in D1 group than that of S group only at 4, 8, and 16 hours after surgery (P < 0.05). Compared with S group, the NRS scores at rest at 1, 4, and 8 hours after surgery and with coughing at 4, 8, 16, and 24 hours after surgery were significantly lower in D2 group (P < 0.05). However, compared with D1 group, the NRS scores both at rest and with coughing at 4 and 8 hours after surgery were significantly lower in D2 group (P < 0.05). The NRS scores both at rest and with coughing show that there were no significant differences between D1 group and S group at each time point after surgery (P > 0.05). LOS of group D2 was higher than S and D1 groups at 1 hour after surgery (P < 0.05), BCS of group D2 was higher than S and D1 groups at 4, 8, and 16 hours after surgery (P < 0.05), and FAS of group D2 was higher than S and D1 groups at 48 and 72 hours after surgery (P < 0.05). The number of rescue analgesia during 72 hours after surgery in D2 group was lower than S and D1 groups (P < 0.05). There were no significant differences among the 3 groups in terms of baseline clinical characteristics and postoperative adverse effects except for itching (P > 0.05).Among the tested patient-controlled analgesia options, the addition of dexmedetomidine (0.04 μg/kg/h) and sufentanil (0.02 μg/kg/h) showed better analgesic effect and greater patient satisfaction without other clinically relevant side effects for highly nicotine-dependent patients during the initial 72 hours after thoracic surgery.Trial Registration: chictr.org (ChiCTR-TRC-14004191).     

Effects of Batroxobin with Continuous Transcranial Doppler Monitoring in Patients with Acute Cerebral Stroke: A Randomized Controlled Trial

Our objective was to determine whether continuous transcranial Doppler (TCD) monitoring could safely enhance the efficacy of batroxobin, a thrombin‐like enzyme extracted from Bothrops atrox moojeni venom, in the treatment for acute cerebral stroke beyond the thrombolytic time window. Ninety patients suffering an acute cerebral stroke were recruited into the study within 12 hours after the onset of symptoms. Patients were randomized to receive batroxobin with (target group) or without 1 hour of continuous TCD monitoring (control group). Clinical evaluation of stroke was based on the National Institutes of Health Stroke Scale (NIHSS) score, Barthel index (BI), Thrombolysis in Brain Ischemia score (TIBI), the incidence of advancing stroke, and the recurrence of cerebral infarction. The patients receiving continuous TCD monitoring showed significant improvement in NIHSS score at 57 days post treatment compared with the control. Similarly, patients receiving continuous TCD monitoring also showed significant improvement in BI at 3 months compared with the controls. Consistently, both the incidence of advancing stroke after 1 week and the incidence of stroke recurrence after 3 months were significantly lower in TCD monitored group than control group. Moreover, the safety of the employment of TCD monitoring in the treatment of these patients was confirmed as there was no significant difference of the incidence of intracranial hemorrhage at 1 week after the treatment between the target and control groups. Taken together, our study showed that batroxobin, in combination with continuous TCD monitoring at the middle cerebral artery, reduced the incidence of advancing stroke and stroke recurrence after treatment without adverse effects in terms of poststroke intracranial hemorrhage.     

Optimization of Vitamin Suppletion After Roux-En-Y Gastric Bypass Surgery Can Lower Postoperative Deficiencies: A Randomized Controlled Trial

Iron, vitamin B12, and folic acid deficiencies are among the most common deficiencies occurring after laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study evaluates the effectiveness of a specially designed multivitamin supplement (WLS Forte, FitForMe, Rotterdam, the Netherlands) specifically developed for LRYGB patients.A triple-blind, randomized, 12-month study was conducted comparing WLS forte with a standard multivitamin supplement (sMVS) containing approximately 100% of the recommended daily allowance (RDA) for iron, vitamin B12, and folic acid. WLS Forte contains vitamin B12 14000% RDA, iron 500% RDA, and folic acid 300% RDA.In total, 148 patients (74 in each group) underwent a LRYGB procedure. Baseline characteristics were similar for both groups. Per protocol analysis demonstrated that sMVS treatment was associated with a decline in ferritin (−24.4 ± 70.1 μg/L) and vitamin B12 (−45.9 ± 150.3 pmol/L) over 12 months, whereas in WLS Forte patients, ferritin remained stable (+3.2 ± 93.2 μg/L) and vitamin B12 increased significantly (+55.1 ± 144.2 pmol/L). The number of patients developing ferritin or vitamin B12 deficiency was significantly lower with WLS Forte compared with sMVS (P < 0.05). Iron deficiency (ID) was reduced by 88% after WLS Forte compared with sMVS. Adverse events related to supplement use did not occur.An optimized multivitamin supplement is safe and reduces the development of iron and vitamin B12 deficiencies after LRYGB.     

Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial

Background

Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction.

Methods

1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants.

Results

541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p?<?0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (β 0.10, 95% CI 0.02–0.18, scale 0–1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p?<?0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters.

Conclusions

While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care.

     

Financial Incentives for Home-Based Health Monitoring: A Randomized Controlled Trial

BACKGROUND

Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases, but daily engagement rates among these patients may be low.

OBJECTIVE

To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes.

DESIGN

Randomized, controlled trial. (Clinicaltrials.gov Identifier: NCT01282957).

PARTICIPANTS

Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5 % recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System.

INTERVENTIONS

Twelve weeks of daily home-monitoring of blood glucose, blood pressure, and weight (control group; n?=?28); a lottery incentive with expected daily value of $2.80 (n?=?26) for daily monitoring; and a lottery incentive with expected daily value of $1.40 (n?=?21) for daily monitoring.

MAIN MEASURES

Daily use of three home-monitoring devices during the three-month intervention (primary outcome) and during the three-month follow-up period and change in A1c over the intervention period (secondary outcomes).

KEY RESULTS

Incentive arm participants used devices on a higher proportion of days relative to control (81 % low incentive vs. 58 %, P?=?0.007; 77 % high incentive vs. 58 %, P?=?0.02) during the three-month intervention period. There was no difference in adherence between the two incentive arms (P?=?0.58). When incentives were removed, adherence in the high incentive arm declined while remaining relatively high in the low incentive arm. In month 6, the low incentive arm had an adherence rate of 62 % compared to 35 % in the high incentive arm (P?=?0.015) and 27 % in the control group (P?=?0.002).

CONCLUSIONS

A daily lottery incentive worth $1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive.