Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

Acid-Base Imbalance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503214
• Other study ID #: Buffer power
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: February 20, 2019

Study information

• Verified date: March 2019
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic patients and healthy volunteers

Exclusion Criteria:

• age < 18 years and pregnancy

Related Conditions & MeSH terms

• Acid-Base Imbalance
• Acidosis
• Alkalosis
• Alkalosis, Respiratory
• Respiratory Acidosis
• Respiratory Alkalosis

Intervention

Diagnostic Test:
• In vitro determination of non-carbonic buffer power
In vitro measurement of the non-carbonic buffer power by the means of equilibration of whole blood and isolated plasma with gas mixtures containing different concentrations of carbon dioxide
• Classic description of acid-base status
Measurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-carbonic buffer power	Non-carbonic buffer power (beta) of whole blood and isolated plasma [expressed as variations in bicarbonate concentration divided by variations in pH).	1 day
Secondary	Strong Ion Difference variations induced by carbon dioxide	Variations in Strong Ion Difference of whole blood and plasma [expressed in milliequivalents per Liter], induced by acute in vitro changes of carbon dioxide	1 day
Secondary	Bicarbonate Variations induced by carbon dioxide	Variations in bicarbonate concentration of whole blood and plasma [expressed in milliequivalents per Liter], induced by acute in vitro changes of carbon dioxide	1 day
Secondary	Oxidized albumin	Oxidized albumin [expressed as percentage of total albumin concentration]	1 day
Secondary	Correlation between hematocrit values and Strong Ion Difference variations	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.	1 day