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