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Related Concept Videos

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

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Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Gentamicin, an aminoglycoside antibiotic, is commonly administered via intermittent intravenous infusion to treat severe infections. An intermittent one-hour infusion of gentamicin, administered at eight-hour intervals, allows for precise control of plasma drug concentrations, minimizing toxicity while ensuring therapeutic efficacy. Pharmacokinetic principles govern the dynamics of plasma concentrations and can be mathematically described using specific equations.The plasma drug concentration...
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

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Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
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Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised

Fernando G Zampieri1, Luciano C P Azevedo2, Thiago D Corrêa3

  • 1Research Institute HCor, Hospital of Coração, São Paulo, Brazil. abiasi@hcor.com.br.

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
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Summary

This study compared balanced crystalloid fluids to saline in critically ill patients, finding no significant difference in 90-day mortality. Fluid infusion rates also did not impact survival outcomes in this large intensive care unit trial.

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Area of Science:

  • Critical Care Medicine
  • Fluid Resuscitation
  • Clinical Trials

Background:

  • The optimal fluid choice for critically ill patients remains debated, with unclear evidence on balanced crystalloid solutions versus saline.
  • The impact of fluid infusion rates on patient outcomes in intensive care is not well-established.

Purpose of the Study:

  • To determine if balanced crystalloid solutions reduce 90-day mortality compared to saline in critically ill patients.
  • To investigate whether slow fluid infusion rates decrease 90-day mortality compared to rapid infusion in this patient population.

Main Methods:

  • The Balanced Solution versus Saline in Intensive Care Study (BaSICS) is a pragmatic, 2x2 factorial, randomized controlled trial.
  • 11,000 patients from over 100 Brazilian intensive care units were randomized to receive either Plasma-Lyte 148 or saline, and assigned to rapid (999 mL/h) or slow (333 mL/h) infusion rates.
  • Blinding of solutions was maintained for patients, providers, and investigators, though infusion rates were not blinded.

Main Results:

  • The primary outcome, 90-day all-cause mortality, was assessed.
  • Secondary outcomes included renal failure requiring RRT, acute kidney injury, non-renal organ dysfunction (SOFA score), and mechanical ventilation-free days.

Conclusions:

  • The BaSICS trial provides robust evidence regarding the comparative effectiveness of balanced crystalloids versus saline in critically ill patients.
  • The study also offers insights into the effect of fluid bolus infusion rates on patient outcomes in the intensive care setting.