Clinical trial NCT03503214: Non Carbonic Buffer Power of Critical Ill Patients With Sepsis
Official title: Changes in Acid-base Variables Induced by Acute Variations in Partial Pressure of Carbon Dioxide in Whole Blood and Isolated Plasma of Septic Critically Ill Patients and Healthy Volunteers: an In-vitro Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acid-Base Imbalance
Respiratory Acidosis
Respiratory Alkalosis
Keywords: Acid-base equilibrium
Stewart's approach
In vitro study
Respiratory acid-base derangements
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock admitted to the ICU will be enrolled. Furthermore, healthy volunteers recruited from ICU staff members and relatives will be enrolled as control group.

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

The human organism is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in case of blood variations in carbon dioxide content. The aim of the present study is to quantify the buffer power, i.e. the capacity to limit pH variations in response to carbon dioxide changes, in critically ill septic patients and compare these results with data collected from healthy volunteers.

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

The human body is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in response to acid-base derangements.

The present study focuses on the acute compensatory mechanisms of respiratory acid-base derangements, i.e., respiratory acidosis and respiratory alkalosis. In this case the non-carbonic buffers are constituted by albumin and phosphates in plasma, with the addition of hemoglobin in whole blood.

Aim of the present in-vitro study is to measure the buffer power of non-carbonic weak acids contained in whole blood and isolated plasma, assess the relative contribution of red blood cells and plasma proteins and perform a comparison between septic patients and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Septic patients and healthy volunteers

Exclusion Criteria:

* age \< 18 years and pregnancy

Primary outcomes:
measure: Non-carbonic buffer power
timeFrame: 1 day
Secondary outcomes:
measure: Strong Ion Difference variations induced by carbon dioxide
timeFrame: 1 day
measure: Bicarbonate Variations induced by carbon dioxide
timeFrame: 1 day
measure: Oxidized albumin
timeFrame: 1 day
measure: Correlation between hematocrit values and Strong Ion Difference variations
timeFrame: 1 day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Thomas Langer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Antonio Pesenti, MD
role: STUDY_DIRECTOR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
name: Giacomo Grasselli, MD
role: STUDY_CHAIR
References: