Plos One
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Randomized Controlled Trial Multicenter Study
Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial.
We aimed to evaluate perioperative outcomes in patients undergoing pancreaticoduodenectomy with or without a cardiac output goal directed therapy (GDT) algorithm. We conducted a multicentre randomised controlled trial in four high volume hepatobiliary-pancreatic surgery centres. We evaluated whether the additional impact of a intraoperative fluid optimisation algorithm would influence the amount of fluid delivered, reduce fluid related complications, and improve length of hospital stay. ⋯ In conclusion, using a surgery-specific, patient-specific goal directed restrictive fluid therapy algorithm in this cohort of patients, can justify using enough fluid without causing oedema, yet as little fluid as possible without causing hypovolaemia i.e. "precision" fluid therapy. Our findings support the use of a perioperative haemodynamic optimization plan that prioritizes preservation of cardiac output and organ perfusion pressure by judicious use of fluid therapy, rational use of vasoactive drugs and timely application of inotropic drugs. They also suggest the need for further larger studies to confirm its findings.
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Randomized Controlled Trial Multicenter Study
8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information.
We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. ⋯ The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias.
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Multicenter Study Observational Study
Validity of the Manchester Triage System in emergency care: A prospective observational study.
To determine the validity of the Manchester Triage System (MTS) in emergency care for the general population of patients attending the emergency department, for children and elderly, and for commonly used MTS flowcharts and discriminators across three different emergency care settings. ⋯ Validity of the MTS in emergency care is moderate to good, with lowest performance in the young and elderly patients. Future studies on the validity of triage systems should be restricted to large, multicenter studies to define modifications and improve generalizability of the findings.
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Multicenter Study Clinical Trial
Correlation of optic nerve sheath diameter with directly measured intracranial pressure in Korean adults using bedside ultrasonography.
The correlation of optic nerve sheath diameter (ONSD) as seen on ultrasonography (US) and directly measured intracranial pressure (ICP) has been well described. Nevertheless, differences in ethnicity and type of ICP monitor used are obstacles to the interpretation. Therefore, we investigated the direct correlation between ONSD and ventricular ICP and defined an optimal cut-off point for identifying increased ICP (IICP) in Korean adults with brain lesions. ⋯ ONSD as seen on bedside US correlated well with directly measured ICP in Korean adults with brain lesions. The optimal cut-off point of ONSD for detecting IICP was 5.6 mm.
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Randomized Controlled Trial Multicenter Study
Decline in CD4 T lymphocytes with monotherapy bridging strategy for non-adherent adolescents living with HIV infection: Results of the IMPAACT P1094 randomized trial.
Management of persistently non-adherent youth living with HIV (YLHIV) with virologic failure (VF) on combination antiretroviral therapy (cART) remains challenging. One strategy has been using 3TC/ FTC monotherapy (3TC/FTC), which in the presence of the M184V resistance mutation, does not suppress viral replication nor select for additional drug resistance mutations, and reduces viral fitness with limited side effects. P1094 compared the immunologic outcome of continuing failing cART vs. switching to 3TC/FTC as a "bridging strategy" to subsequent suppressive cART for non-adherent YLHIV with pre-existing M184V resistance. ⋯ Non-adherent participants randomized to 3TC/FTC were more likely than those maintained on failing cART to experience a confirmed decline in CD4+ count of ≥30%. Although this study suffers from limitations of small sample size and premature discontinuation, the randomized comparison to continuing failing cART indicates that 3TC/FTC provides inferior protection from immunologic deterioration for non-adherent youth with M184V resistance. Better alternatives to 3TC/FTC such as ART with higher barriers to resistance and novel adherence and treatment strategies for nonadherent youth are urgently needed.