79 research outputs found
A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes.</p> <p>Methods/Design</p> <p>A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates.</p> <p>Discussion</p> <p>Several aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic.</p> <p>Trial Registration Number</p> <p><a href="http://www.controlled-trials.com/ISRCTN45190901">ISRCTN45190901</a></p
Perioperative fluid and volume management: physiological basis, tools and strategies
Fluid and volume therapy is an important cornerstone of treating critically ill patients in the intensive care unit and in the operating room. New findings concerning the vascular barrier, its physiological functions, and its role regarding vascular leakage have lead to a new view of fluid and volume administration. Avoiding hypervolemia, as well as hypovolemia, plays a pivotal role when treating patients both perioperatively and in the intensive care unit. The various studies comparing restrictive vs. liberal fluid and volume management are not directly comparable, do not differ (in most instances) between colloid and crystalloid administration, and mostly do not refer to the vascular barrier's physiologic basis. In addition, very few studies have analyzed the use of advanced hemodynamic monitoring for volume management
The application of Western management to the development of a management education programme in Bahrain
Management education and development are recognised as
highly problematic in advanced industrial societies
that have a relatively long tradition of management
theory and practice. Problems of developing managerial
competence become all the more acute in non-Western
societies that require the transfer of managerial
know-how from external, mainly Western sources.
The focus of this thesis is Continuing Management
Education as a vehicle for Management Development with
special reference to Bahrain as a transitional
society. The investigation serves as a context for
evaluating the transferability of selected Western
Management theories to non-Western *environments.
Special emphasis is placed on the concepts of
leadership, motivation and managerial professionalism,
following a detailed empirical investigation of the
Bahrain management culture at the macro, intermediate
and micro levels. A strategy for Continuing Management
Education is designed within the broader context of
scanning four major management development options
available to Bahrain, namely Westernisation,
Bahrainisation, Japanisation and Pragmatisation. The
latter option is recommended in the light of evidence
generated through a collaborative approach involving an
extensive survey of the management community. The
strategy is applied to Bahrain through evaluating Gulf
Polytechnic's Continuing Management Education Programme
(COMEP) against it and identifying areas where specific
correctives are needed. An explicit attempt is made to
develop some guidelines pertinent to cross-cultural
management theory transfer with special reference to
such variables as specificity of a particular theory,
its level of analysis and its methodological
structure. At a parallel level, an effort is made to
derive pertinent lessons of experience; both in policy
terms and on theoretical grounds, out of the Bahrain
case by way of a series of tentative generalizations
whose applicability extends beyond Bahrain to the Gulf
region, the Middle East and possibly other transitional
societies.
The research is based on a processual-developmental
qualitative methodology and amounts to a managerial
evaluation of a particular body of management theory
and practice. This choice was partly influenced by the
author's duality of roles as researcher and director of
a major institution of higher learning. A future
research agenda is also charted out
Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children
Background. Enteral acetaminophen, when used alone, is not very effective for postoperative analgesia because of delayed absorption and sub-therapeutic plasma concentrations. In contrast, i.v. acetaminophen is devoid of these shortcomings and could potentially provide adequate postoperative analgesia as a single agent. This randomized double-blind study compared the analgesic effects of i.v. acetaminophen and i.m. meperidine in paediatric patients undergoing tonsillectomy
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