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Biomedical subjects

Marlena M Wald

Publications and source records attributed to Marlena M Wald.

6 recordsLinked to original sources

ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury.

STUDY OBJECTIVE: Laboratory evidence indicates that progesterone has potent neuroprotective effects. We conducted a pilot clinical trial to assess the safety and potential benefit of administering progesterone to patients with acute traumatic brain injury. METHODS: This phase II, randomized, double-blind, placebo-controlled trial was conducted at an urban Level I trauma center. One hundred adult trauma patients who arrived within 11 hours of injury with a postresuscitation Glasgow Coma Scale score of 4 to 12 were enrolled with proxy consent. Subjects were randomized on a 4:1 basis to receive either intravenous progesterone or placebo. Blinded observers assessed patients daily for the occurrence of adverse events and signs of recovery. Neurologic outcome was assessed 30 days postinjury. The primary safety measures were differences in adverse event rates and 30-day mortality. The primary measure of benefit was the dichotomized Glasgow Outcome Scale-Extended 30 days postinjury. RESULTS: Seventy-seven patients received progesterone; 23 received placebo. The groups had similar demographic and clinical characteristics. Laboratory and physiologic characteristics were similar at enrollment and throughout treatment. No serious adverse events were attributed to progesterone. Adverse and serious adverse event rates were similar in both groups, except that patients randomized to progesterone had a lower 30-day mortality rate than controls (rate ratio 0.43; 95% confidence interval 0.18 to 0.99). Thirty days postinjury, the majority of severe traumatic brain injury survivors in both groups had relatively poor Glasgow Outcome Scale-Extended and Disability Rating Scale scores. However, moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo. CONCLUSION: In this small study, progesterone caused no discernible harm and showed possible signs of benefit.

Accidents, Traffic↗

Evaluation and treatment of patients with severely elevated blood pressure in academic emergency departments: a multicenter study.

STUDY OBJECTIVE: Current guidelines advise that emergency department (ED) patients with severely elevated blood pressure be evaluated for acute target organ damage, have their medical regimen adjusted, and be instructed to follow up promptly for reassessment. We examine factors associated with performance of recommended treatment of patients with severely elevated blood pressure. METHODS: Observational study performed during 1 week at 4 urban, academic EDs. Severely elevated blood pressure was defined as systolic blood pressure greater than or equal to 180 mm Hg or diastolic blood pressure greater than or equal to 110 mm Hg on at least 1 measurement. ED staff were blinded to the study purpose. Demographics, presenting complaints, vital signs, tests ordered, medications administered, disposition, and discharge instructions were recorded, and associations were tested in bivariate analyses. RESULTS: Severely elevated blood pressure was noted in 423 patients. Serum chemistry was obtained in 73% of patients, ECG in 53% of patients, chest radiograph in 46% of patients, urinalysis in 43% of patients, and funduscopy documented in 36% of patients. All studies were performed in 6% of patients and were associated with complaints of dyspnea (odds ratio [OR] 3.1; 95% confidence interval [CI] 1.1 to 8.7) and chest pain (OR 3.0; 95% CI 1.2 to 7.6). Oral antihypertensives were administered to 36% of patients and were associated with blood pressure-related complaints (OR 2.0 [1.2 to 3.3]), patient-suspected severely elevated blood pressure (OR 5.6, 95% CI 2.0 to 15.3), and being uninsured (OR 2.0; 95% CI 1.2 to 3.3). Intravenous antihypertensives were given to 4% of patients, associated only with chest pain (OR 3.2; 95% CI 1.1 to 9.5). Modification of antihypertensive regimen was documented in 19% of discharged patients and associated with patient-suspected severely elevated blood pressure (OR 5.5; 95% CI 2.5 to 12.2) and being uninsured (OR 1.8; 95% CI 1.1 to 2.9). CONCLUSION: The majority of ED patients with severely elevated blood pressure do not receive the evaluation, medical regimen modification, and discharge instructions advised by current guidelines. Further study is necessary to determine whether these recommendations are appropriate in this setting.

Academic Medical Centers↗

Elevated blood pressure in urban emergency department patients.

OBJECTIVES: There has been little systematic study of emergency department (ED) patients with elevated blood pressure (BP) values. The authors sought to characterize ED patients with elevated BP values, assess presenting symptoms, and determine the prevalence of elevated BP after discharge. METHODS: This was a cross-sectional study performed in four academic EDs. Adults presenting with systolic BP >or=140 mm Hg or diastolic BP >or=90 mm Hg were enrolled over a one-week equivalent period. Demographics, medical history, and symptoms were obtained by chart abstraction and structured interview. A random patient subset underwent a three-week follow-up interview. BP measurements were staged, using Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-VI) criteria, according to the greatest value noted in the ED. RESULTS: A total of 1,396 patients were enrolled. Stage 1 BP values were noted in 44.3%, stage 2 in 25.3%, and stage 3 in 30.3%. African American patients more frequently had stage 2 and 3 BP values than other ethnic groups. BP measurements were repeated in 61.1% of patients and were the same or greater in 51.3% of patients. Dyspnea was associated with greater BP values. Among the 63.9% of patients who were interviewed, 52.7% were not being treated for hypertension, and 42.1% of those with hypertension had recently missed a medication dose. Follow-up was obtained in 74.7% of those targeted. A visit to a medical practitioner since discharge was reported by 63.2%; of these, 26.1% reported that their BP remained elevated. CONCLUSIONS: Elevated BP is common among ED patients. African American patients are more likely than those of other ethnic groups to have greater BP values. The ED visit may be a good opportunity to identify patients with unrecognized or poorly controlled hypertension.

Black or African American↗

Proxy identification: a time-dependent analysis.

OBJECTIVES: To describe the availability of next-of-kin (NOK) for proxy consent over the 24-hour time period following presentation of major trauma patients to a Level I trauma center. METHODS: The study was conducted by using a prospective, observational study design. Consecutive patients meeting predefined major trauma criteria during a three-month study period were enrolled and followed until NOK were contacted, or up to 24 hours. Survival analysis was used to determine the probability of NOK contact during the 24-hour follow-up period. RESULTS: Three hundred fifty (92%) of 382 subjects had NOK contacted during the follow-up period. The probabilities (95% confidence intervals [CIs]) of NOK contact at the time of arrival (t = 0) and 2, 4, 6, and 24 hours postpresentation were 0.25 (95% CI = 0.21 to 0.30), 0.68 (95% CI = 0.63 to 0.72), 0.77 (95% CI = 0.73 to 0.82), 0.80 (95% CI = 0.76 to 0.84), and 0.87 (95% CI = 0.84 to 0.90), respectively. The median time to contact was 40 minutes (95% CI = 27 to 54 min). CONCLUSIONS: One third of the trauma patients in this study did not have NOK available two hours following arrival in the emergency department. For time-critical research protocols, the time to NOK contact can significantly impact the ability to ensure prompt enrollment and treatment in clinical trials. Further studies are needed to assess the generalizability and consistency of these data.

Adult↗

The epidemiology and impact of traumatic brain injury: a brief overview.

Traumatic brain injury (TBI) is an important public health problem in the United States and worldwide. The estimated 5.3 million Americans living with TBI-related disability face numerous challenges in their efforts to return to a full and productive life. This article presents an overview of the epidemiology and impact of TBI.

Brain Injuries↗