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临床试验/NCT03966664
NCT03966664Unknown不适用

Determination of Ka of Isolated Plasma and Whole Blood of Critically Ill Patients With Sepsis, Non-septic Patients and Healthy Volunteers: an International, In-vitro Acid-base Study.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Effective dissociation constant of plasma weak acids (Ka) [dimensionless]

研究概览

简要总结

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

详细描述

Acid-base equilibrium has been object of study for more than 100 years in medicine because of its relevance in patients' management and in determining their prognosis, especially in the ICU.

A concept closely related to acid-base equilibrium is that of "buffer", term used to define any substance able to limit the changes in pH caused by the addition or loss of alkali or acid.

Depending on its physiochemical features, every buffer has one or more pH (negative logarithm of hydrogen ion concentration) values where its ability to keep pH stable is maximal. These values are defined as Ka or semi equivalence points, i.e. the pH values where the buffer dissolved in solution is half in its associated form (AH) and half in its dissociated form (A-).

Several studies tried to determine the normal values of both concentration and Ka of ATOT. However, they did not lead to univocal results. Moreover, many of these values come from studies of veterinary medicine or are the result of theoretical estimates on human plasma.

Staempfli and Constable performed a single experimental study on human plasma in 2003. These authors, however, analyzed only isolated plasma, neglecting whole blood, and computed ATOT and Ka values of healthy volunteers, while Ka and ATOT values for critically ill patients with sepsis are still unknown.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Effective dissociation constant of plasma weak acids (Ka) [dimensionless]

时间窗: 1 day

Difference in plasma Ka between study groups.

次要结局

  • Total concentration of whole blood non-volatile buffers (Atot) [mmol/L](1 day)
  • Non-carbonic buffer power of whole blood due to electrolyte shifts [milliequivalents/L](1 day)
  • Characterization of altered ligand binding properties(1 day)
  • Effective dissociation constant of whole blood weak acids (Ka) [dimensionless](1 day)
  • Non-carbonic buffer power of isolated plasma due to electrolyte shifts [milliequivalents/L](1 day)
  • Total concentration of plasma non-volatile buffers (Atot) [mmol/L](1 day)
  • Oxidized albumin [%](1 day)
  • Identification of differentially modified proteoforms of human serum albumin (HSA) and major plasma proteins.(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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