Neurocritical care
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Randomized Controlled Trial
The effects of fluid balance and colloid administration on outcomes in patients with aneurysmal subarachnoid hemorrhage: a propensity score-matched analysis.
Delayed ischemic neurological deficit (DIND) following aneurysmal subarachnoid hemorrhage (SAH) remains a significant cause of mortality and disability. The administration of colloids and the induction of a positive fluid balance during the vasospasm risk period remain controversial. Here, we compared DIND and outcomes among propensity score-matched cohorts who did and did not receive colloids and also tested the effect of a positive fluid balance on these endpoints. ⋯ Colloid administration and induction of a positive fluid balance during the vasospasm risk period may be associated with poor outcomes in specific patient groups. Patient selection is of utmost importance when managing the fluid status of patients with aneurysmal SAH.
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Randomized Controlled Trial Multicenter Study
High Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF) Trial: Rationale, Design, and Methods.
Hemoglobin degradation products, in particular iron, have been implicated in secondary neuronal injury following intracerebral hemorrhage (ICH). The iron chelator Deferoxamine Mesylate (DFO) exerts diverse neuroprotective effects, reduces perihematoma edema (PHE) and neuronal damage, and improves functional recovery after experimental ICH. We hypothesize that treatment with DFO could minimize neuronal injury and improve outcome in ICH patients. As a prelude to test this hypothesis, we conducted a Phase I, open-label study to determine the tolerability, safety, and maximum tolerated dose (MTD) of DFO in patients with ICH. Intravenous infusions of DFO in doses up to 62 mg/kg/day (up to a maximum of 6000 mg/day) were well-tolerated and did not seem to increase serious adverse events (SAEs) or mortality. We have initiated a multi-center, double-blind, randomized, placebo-controlled, Phase II clinical trial (High Dose Deferoxamine [HI-DEF] in Intracerebral Hemorrhage) to determine if it is futile to move DFO forward to Phase III efficacy evaluation. ⋯ The Hi-Def trial is expected to advance our understanding of the pathopgysiology of secondary neuronal injury in ICH and will provide a crucial "Go/No Go" signal as to whether a Phase III trial to investigate the efficacy of DFO is warranted.
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Randomized Controlled Trial Comparative Study
A prospective evaluation of labetalol versus nicardipine for blood pressure management in patients with acute stroke.
Acute hypertension is common following stroke and contributes to poor outcomes. Labetalol and nicardipine are often used for acute hypertension but there are little data comparing the two. This study is to evaluate the therapeutic response and tolerability of these two agents following acute stroke. ⋯ In acutely hypertensive stroke patients, superior therapeutic response was achieved with nicardipine versus labetalol. Despite this, there was no demonstrable difference in clinical outcomes.
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Randomized Controlled Trial Comparative Study
Antibiotic-impregnated versus silver-bearing external ventricular drainage catheters: preliminary results in a randomized controlled trial.
Evaluation of antibiotic-impregnated (AI) and ionized silver particle coated external ventricular drainage catheters (EVD) in patients with subarachnoid (SAH) or intracranial hemorrhage (ICH). ⋯ Regarding CSF infection rate and dysfunction, no statistical significant differences between the two EVD catheters Bactiseal(®) versus VentriGuard(®) were found. The silver-bearing catheter might offer a safe and cost-conscious alternative to the AI catheter.
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Randomized Controlled Trial
Long-term outcomes of post-thrombolytic intracerebral hemorrhage in ischemic stroke patients.
Intracerebral hemorrhage (ICH) is an infrequent complication of intravenous recombinant tissue plasminogen activator (rt-PA) for the treatment of acute stroke. However, such ICH is an important reason for withdrawal of care because of lack of adequate data regarding long-term patient outcomes. ⋯ Approximately 30 % of patients with post-thrombolytic ICH have favorable outcomes at 1 year which does not support early withdrawal of care. Ascertainment of NIHSS score and worsening of NIHSS score at 7-10 days may be necessary for accurate prognostic stratification.