Sepsis Clinical Trial
Official title:
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.
Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.
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.
Primary aim of the present study is to quantify the acidic dissociation constant (Ka) of
isolated plasma of critically ill patients with sepsis, and compare these data with normal
values, i.e. obtained from healthy controls. The investigators hypothesize that plasma of
critically ill septic patients has a lower Ka and that, consequently, it undergoes higher pH
variations for a given perturbation of the system (variation in carbon dioxide).
Secondary aim is to quantify the Ka of whole blood of critically ill patients with sepsis and
compare these data with normal values, i.e. obtained from healthy controls. The investigators
hypothesize that blood of critically ill septic patients has a lower Ka and that,
consequently, it undergoes higher pH variations for a given perturbation of the system
(variation in carbon dioxide).
Other aims of the study are:
- quantify the Ka of plasma and whole blood of non-septic patients admitted to the ICU and
compare these results with the values of septic patients and healthy volunteers.
- define the normal concentration of weak non-carbonic acids (ATOT) in plasma of septic
patients and compare it with data obtained in healthy volunteers and non-septic
patients.
Finally, possible structural alteration of plasma proteins will be evaluated:
- Identification of differentially modified proteoforms of serum albumin and major plasma
proteins by two-dimensional electrophoresis;
- High Performance Liquid Chromatography (HPLC) to identify different Redox-forms of
albumin
- Spectrophotometric evaluation of modifications of ligand binding properties of serum
albumin.
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