Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

Completed

• Conditions: Respiratory Alkalosis; Acid-Base Imbalance; Respiratory Acidosis
• Interventions: Diagnostic Test: In vitro determination of non-carbonic buffer power; Diagnostic Test: Classic description of acid-base status

• Registration Number: NCT03503214
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Study Start: 2018-03-07
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-19
• Primary Completion: 2019-02-20
• Study Completion: 2019-02-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Septic patients and healthy volunteers

Exclusion Criteria

• age < 18 years and pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic patients	Classic description of acid-base status	Patients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit
Healthy volunteers	In vitro determination of non-carbonic buffer power	Subjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases.
Healthy volunteers	Classic description of acid-base status	Subjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases.
Septic patients	In vitro determination of non-carbonic buffer power	Patients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit

Primary Outcome Measures

Name	Time	Method
Non-carbonic buffer power	1 day	Non-carbonic buffer power (beta) of whole blood and isolated plasma \[expressed as variations in bicarbonate concentration divided by variations in pH).

Secondary Outcome Measures

Name	Time	Method
Strong Ion Difference variations induced by carbon dioxide	1 day	Variations in Strong Ion Difference of whole blood and plasma \[expressed in milliequivalents per Liter\], induced by acute in vitro changes of carbon dioxide
Oxidized albumin	1 day	Oxidized albumin \[expressed as percentage of total albumin concentration\]
Correlation between hematocrit values and Strong Ion Difference variations	1 day	Correlation between hematocrit \[expressed as percentage\] values and Strong Ion Difference variations \[expressed in mEq/L\] induced by acute in vitro changes of Carbon Dioxide.; Acute variations in partial pressure of carbon dioxide cause changes in Strong Ion Difference. The hypothesis is that the magnitude of Strong Ion Difference variations correlate to the hematocrit, being the red blood cell the major source of electrolytes. The higher the hematocrit, the higher the possible change in Strong Ion Difference induced by acute variations in partial pressure of carbon dioxide.
Bicarbonate Variations induced by carbon dioxide	1 day	Variations in bicarbonate concentration of whole blood and plasma \[expressed in milliequivalents per Liter\], induced by acute in vitro changes of carbon dioxide

Trial Locations

Locations (1)

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy