ABSTRACT
BACKGROUND: Hypertensive emergency is commonly associated with acute ischemic stroke and can be a predictor of poor outcome in these patients. Nicardipine and labetalol are commonly administered for the treatment of acute hypertension following stroke. Yet, data are lacking on the safety of these agents in this setting. OBJECTIVE: This study aimed to determine all-cause in-hospital mortality, medication-related hypotensive episodes, development of hospital acquired infections and hospital length of stay between nicardipine and labetalol use for the management of hypertension after acute ischemic stroke. METHODS: This retrospective study used a prospective database of individuals admitted to the neurointensive care unit at a university-based hospital over 39 months. Patients with confirmed ischemic strokes were included in this analysis. Data were recorded for administration of nicardipine and labetalol following acute stroke. RESULTS: A total of 244 patients with acute ischemic stroke were included in this analysis (mean age, 64.3 ± 15 years; 52.2% males). Nicardipine use after acute ischemic stroke was associated with an increased risk of 30-day mortality (odds ratio [OR]: 4.6, 95% confidence interval [CI] 1.3-15.7; P = .02). A single episode of hypotension in the first 72hours of admission was also significantly associated with mortality (OR 4.35 [95% CI 1.2-14.9]; P = .02). CONCLUSIONS: Nicardipine was associated with an increased risk of short-term mortality after acute ischemic stroke. This may have been due to hypotension, tachycardia, or pulmonary edema which were not apparent in our study. Further studies are required to elucidate the cause of this association.
Subject(s)
Antihypertensive Agents/adverse effects , Brain Ischemia/drug therapy , Brain Ischemia/mortality , Hospital Mortality , Hypertension/drug therapy , Hypertension/mortality , Nicardipine/adverse effects , Stroke/drug therapy , Stroke/mortality , Aged , Blood Pressure/drug effects , Brain Ischemia/diagnosis , Brain Ischemia/physiopathology , Critical Illness , Databases, Factual , Female , Humans , Hypertension/diagnosis , Hypertension/physiopathology , Hypotension/chemically induced , Hypotension/mortality , Hypotension/physiopathology , Labetalol/adverse effects , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/physiopathology , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. METHODS: Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. RESULTS: A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. CONCLUSIONS: The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.
Subject(s)
Comprehension , Counseling/methods , Group Processes , Informed Consent/ethics , Adult , Child , Child, Preschool , Comprehension/ethics , Dietary Supplements , Female , Humans , Male , Minors , Parents , Surveys and Questionnaires , Time Factors , Treatment FailureABSTRACT
OBJECTIVE: To evaluate the effectiveness of a locally made ready-to-use therapeutic food (RUTF) in decreasing mild to moderate malnutrition. DESIGN: A randomized open label, controlled trial. SETTING: Pre-schools run by the Department of Community Health in Kaniyambadi administrative block, Vellore, India; duration of follow-up 3 months from the date of recruitment. PARTICIPANTS: Pupils aged 18 -60 months with Weight-for-Age 2 SD. INTERVENTIONS: A locally produced energy-dense supplement (RUTF), and the current standard of care [teaching caregivers how to make a fortified cereal-milk supplement called High Calorie Cereal Milk (HCCM)]. MAIN OUTCOME MEASURES: Increase in weight-for-age status; increase in levels of plasma zinc, vitamin B12, serum albumin and haemoglobin. RESULTS: The Mean (SD) weight gain at 3 months was higher in the RUTF group: RUTF (n=51): 0.54 kg; (SE = 0.05; 95% CI = 0.44 - 0.65) vs HCCM (n=45): 0.38 kg;(SE = 0.06; 95% CI = 0.25 - 0.51), P = 0.047. The weight gain per kilogram of body weight was directly proportional to the severity of malnutrition. CONCLUSIONS: Community-based treatment showed weight gain in both groups, the gain being higher with RUTF.