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Biomedical subjects

Manish M Patel

Publications and source records attributed to Manish M Patel.

15 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↗

Does the clinical use of ethanol-based hand sanitizer elevate blood alcohol levels? A prospective study.

BACKGROUND: Ethanol-based hand sanitizers (EBHSs) are used in most health care facilities in the United States. Infection control personnel advocate the use of generous quantities of EBHS before and after contact with patients. Although it is assumed that little systemic absorption of ethanol occurs during EBHS use, many alcohols are absorbed to varying degrees via the transdermal route. Ethanol intoxication by employees in the medical workplace is a potentially serious finding, and it is of forensic and medical-legal importance to elucidate the effects of frequent use of EBHS upon serum blood ethanol levels (BELs). To investigate the effect of frequent use of EBHS upon serum blood ethanol concentrations, we prospectively studied 5 volunteers undergoing frequent application of EBHS. METHODS: Enrolled subjects applied 5 mL of the product (62% denatured ethyl alcohol manufactured by Kimberley-Clark, Roswell, GA) to both hands and rubbed until dry. This activity was repeated 50 times over 4 hours. Participants had their blood drawn before as well as after completing the study. Each participant was without alcohol exposure during the 12 hours preceding the study. RESULTS: Five volunteers were enrolled. All had an initial blood ethanol level of less than 5 mg/dL. All 5 participants completed the 4-hour study. There were no noted adverse reactions during the study. Blood ethanol level upon completion of the 50 applications of EBHS was less than 5 mg/dL in all 5 study participants. CONCLUSION: The results of this study demonstrate that use of ethanol-based hand sanitizers, when frequently used in accordance with labeling, do not raise serum blood ethanol levels.

Administration, Cutaneous↗

Recognition of illness associated with covert chemical releases.

Public health threats from intentional releases of chemicals into the environment (ie, chemical terrorism) are an increasing concern in the United States. Recent situations of deliberate contamination of food and beverages with chemicals highlight the need for health care providers and public health officials to be alert for adult and pediatric patients in their communities who have signs and symptoms consistent with chemical exposures. In an effort to increase knowledge of surveillance and preparedness for illness related to potential chemical releases, we provide guidance to health care providers and public health personnel for recognizing illnesses or patterns of illnesses that might be associated with the intentional, covert release of chemical agents. In this article, we will discuss 5 examples of outbreaks of illnesses after a covert chemical release, obstacles to recognition of these illnesses, clues (ie, epidemiological patterns and syndromic presentations) that might enhance the recognition of illnesses from a covert chemical release, and public health strategies to enhance the rapid identification of a chemical terrorism event.

Chemical Terrorism↗

Treatment of imported fire ant stings with mitigator sting and bite treatment--a randomized control study.

OBJECTIVE: To evaluate the efficacy of the commercially available product Mitigator Sting and Bite Treatment in reducing the pain after imported fire ant stings. METHODS: Twenty-four volunteer subjects were exposed to imported fire ant stings on both fore-arms. The subjects received Mitigator paste on 1 arm and calamine lotion on the opposite arm, in a blinded manner, from 90 seconds to 10 minutes after exposure. Subjects recorded pain on a 100-mm visual analog scale 60 seconds, 20 minutes, and 3 days after exposure. A 2-tailed paired t test was used to compare the difference in reduction of pain over time between the Mitigator-treated arms and the calamine-treated arms. RESULTS: At 60 seconds, the mean visual analog scale pain score was 23.9 mm for the Mitigator group and 24.5 mm for the calamine group. At 20 minutes, the mean score was 7.6 mm (delta = 16.3) for the Mitigator group and 12.7 mm (delta = 11.8) for the calamine group. At 3 days, the mean score was 2.4 mm (delta = 21.5) for the Mitigator group and 2.9 mm (delta = 21.6) for the calamine group. There was no significant difference between groups for change in visual analog scale pain score at 60 seconds, 20 minutes (P = .256), or 3 days (P = .64). CONCLUSIONS: There was no significant difference in pain relief between calamine and Mitigator for imported fire ant stings.

Adolescent↗

Case definitions for chemical poisoning.

When human illness results from an unintentional or intentional release of a toxin (chemicals produced by metabolism in an organism [e.g., ricin]) or a toxicant (natural or synthetic chemicals not metabolically produced by an organism [e.g., nerve agents]) into the environment, uniform reporting is necessary to direct appropriate resources, assess the extent of morbidity and mortality, track poisoned persons, and monitor response to intervention. In this report, CDC presents case definitions to facilitate uniform reporting among local, state, and federal public health agencies of illness resulting from a chemical release. The report also explains the rationale for the structure of the case definitions, the audience for whom it is intended, the setting in which the case definitions might be used, and reasons each chemical presented in the report was selected. Clinical knowledge and diagnostic tools (e.g., biologic laboratory tests) for detecting chemical poisoning are likely to improve over time. CDC will create new case definitions and revise existing definitions to meet the needs related to emerging threats and to enhance case definition sensitivity and specificity, when possible, with developing clinical information.

Chemical Warfare↗

Procedural sedation and analgesia in the emergency department: what are the risks?

The practitioner of emergency medicine is routinely faced with patients in need of emergent procedures and pain control and sedation. Our challenge is to make our patients' experiences as painless and as safe as possible, while maximizing our ability to perform the procedure at hand; this is not always an easy task given the propensity of each human body to react differently to interventions and stimuli. We can best meet this challenge by understanding how our patients and pharmaceutical agents intermingle in the risk-benefit equation we formulate before starting our "experiment." Coupling this information with fundamentally sound patient care and monitoring will minimize bad experiences with PSA for both the patient and practitioner.

Adverse Drug Reaction Reporting Systems↗

Methylenedioxymethamphetamine (ecstasy)-related hyperthermia.

MDMA (or 3, 4 methylenedioxymethamphetamine) was first manufactured in the 1920s and found to have structural similarities to both mescaline and amphetamines. Used briefly by some therapists in the 1970s and early 1980s as an adjunct to psychotherapy, it is now primarily abused by teenagers and young adults as an illicit recreational drug known as "ecstasy." As its popularity has increased, so have the number of fatalities and adverse events related to its use. We report six patients suffering fatal or life-threatening hyperthermia after MDMA use. These cases illustrate that hyperthermia associated with MDMA use cannot be solely attributed to rave parties (high ambient temperatures, excessive dancing, dehydration, and overcrowded conditions), drug contaminants, or co-ingestants. A better understanding of the etiology of hyperthermia after MDMA use is needed so that appropriate harm-reduction measures can be developed and instituted.

Adolescent↗

Methylenedioxymethamphetamine (ecstasy)-related myocardial hypertrophy: an autopsy study.

BACKGROUND: Myocardial hypertrophy is a well-recognized complication of cocaine and methamphetamine abuse and is a strong, independent risk factor for sudden death, myocardial infarction, and congestive heart failure. We sought to determine if use of MDMA (methylenedioxyamphetamine or "ecstasy") is associated with myocardial hypertrophy at death. METHODS AND RESULTS: A matched, retrospective study using medical examiner (ME) death reports. Consecutive MDMA positive (+) and MDMA negative (-) deaths identified from MEs in 10 states and a local county, respectively. Five MDMA(-) cases were matched to each MDMA(+) case for age, sex, and ethnicity. MDMA(+) cases were confirmed using GC/MS and other drugs of abuse (e.g., cocaine and methamphetamine) were absent. Matched MDMA(-) cases were trauma fatalities with intact hearts and blood negative for all illicit stimulants. Cardiac weights were compared between the two groups. Twenty seven MDMA(+) deaths and 135 matched MDMA(-) deaths were enrolled. Mean age was 20 years (range 16--33 years); 44% were female. 70.4% were Caucasian, 14.8% African-American, 11.1% Asian, and 3.7% Hispanic. Mean heart weight of MDMA(+) fatalities was 315.7 and 277.2g for MDMA(-) fatalities (Diff=38.5 g; 95% CI=18.3--8.7). Multivariate analysis revealed that MDMA(+) fatalities were more likely to have an enlarged heart (OR=18.3; 95% CI=3.6--1.6). CONCLUSION: The findings of this study suggest that MDMA users might also be at risk for myocardial hypertrophy and possible cardiac toxicity, similar to other stimulants.

Adolescent↗

Shedding new light on the "safe" club drug: methylenedioxymethamphetamine (ecstasy)-related fatalities.

OBJECTIVES: To report the pathology, toxicology, cause, and manner of death in 3,4-methylenedioxymethamphetamine (MDMA)-associated fatalities in the United States. Although use trends are increasing, data regarding the hazards of MDMA are limited. METHODS: The authors obtained fatality reports from participating medical examiners in the United States. Cases were identified as "drug-unrelated" when MDMA did not directly cause death (e.g., motor vehicle collision); deaths from drug toxicity were judged "drug-related." RESULTS: Thirty-eight (8%) of the surveyed medical examiners reported 102 deaths associated with MDMA use from 1999 to 2001. Ten percent of fatalities occurred in 1999 and 90% thereafter, representing a 400% relative increase. Victims tended to be young (mean age = 25), white (n = 87 [85%]), male (n = 70 [69%]), and otherwise healthy. Seventy-one (70%) deaths were drug-related (DR) and 31 (30%) were drug-unrelated (DU). Twenty-four (35%) DR deaths had a mean delay of 6.7 hours (95% CI = 5.1 to 8.2) in activating emergency medical services. Fifty-five DR cases (81%) were found in asystole and pronounced dead at the scene. CONCLUSIONS: The MDMA-associated fatal events typically occur in young, otherwise healthy individuals. MDMA's impact on the public health and safety of young adults and teenagers needs further assessment.

Adolescent↗

Persistent hiccups associated with intravenous corticosteroid therapy.

Singulata, commonly known as hiccups, have many causes and are most often idiopathic and short-lived. Occasionally, hiccups can be persistent and becoming quite bothersome, distracting, and even disabling. Many medications have been implicated as a cause of hiccups. Although uncommon, corticosteroids and benzodiazepines are 2 classes of drugs most frequently associated with the development of hiccups. The following case series describes 5 patients with intravenous corticosteroid-associated hiccups reported to our adverse drug reaction reporting system between January 1998 and December 2000. Physicians using intravenous corticosteroids should be aware of this potential complication.

Journal Article↗

Superwarfarin and glass ingestion with prolonged coagulopathy requiring high-dose vitamin K1 therapy.

A 23-year-old man was brought to the emergency department after eating four boxes of brodifacoum-containing rodenticide over a 4-day interval and pieces from approximately two bottles of glass over the previous 2 weeks. He was asymptomatic but his prothrombin time was markedly elevated with an international normalized ratio (INR) of 37.8. A plain abdominal film showed diffuse radiopaque foreign bodies, presumably glass, in the large and distal small intestines. Treatment for ingested glass consisted of stool softeners and bulk-forming laxatives. The patient developed mild gingival bleeding and received fresh frozen plasma (FFP) infusions and vitamin K1 orally. At a vitamin K1 dosage of 300 mg/day, the INR corrected to less than 2.0 and the patient was discharged taking that dosage. He returned 26 days later with hematuria and flank pain, and his INR was 189. He was administered FFP and packed red blood cells, and his vitamin K1 dosage was increased to 800 mg/day; his INR returned to baseline. Compliance with taking the vitamin K1, which required ingestion of 60-160 tablets/day, was a serious problem, requiring numerous follow-up calls and visits to the patient at home and work. At 5-month follow he was doing well. Compliance with large daily doses of vitamin K1 for treatment of "superwarfarin" ingestion may be poor because of the duration of treatment and large number of pills required. A more concentrated formulation may be advantageous for management of patients with brodifacoum poisoning.

4-Hydroxycoumarins↗

ED utilization of computed tomography in a poisoned population.

The objective of this prospective, analytic study was to identify predictors and describe the demographic and clinical correlates of head computed tomography (CT) evaluation in patients with poisoning or drug overdose and altered mental status. Forty-three patients that were evaluated by head CT and 109 that were not evaluated by head CT were entered into the study at a poison control center. None of the 43 scanned patients had any acute findings on head CT. A logistic regression model yielded 4 predictors that were statistically associated with the ordering of a head CT scan: Glasgow Coma Scale (GCS) < or = 8 (odds ratio [OR]: 2.3; 95% confidence interval [CI] 1.03-5.7); age > or = 41 years (OR 5.3; 95% CI 2.2-13); use of drugs or abuse by history (OR 2.8; 95% CI 1.04-7.6); and witnessed seizure activity (OR 4.8; 95% CI 1.3-17.9). We also tested 2 additional models to identify predictors of hospital admission, 1 with and 1 without CT scan included as a covariate. In the first model, only GCS </=8 was a significant predictor of admission (OR 10.7; 95% CI 2.4-47.2). When the use of head CT was added to the second model, it also emerged as an independent explanatory predictor of admission (OR 4.8; CI 95% 1.2-20.4) in addition to GCS (OR 10.1; 95% CI 2.2-45.4). In this pilot study, patients presenting to the emergency department (ED) with suspected poisoning or drug overdose were found to have a low likelihood of abnormal findings on head CT scan. Those among whom CT scans were obtained were more likely to be admitted to the hospital from the ED, despite negative findings.

Adult↗