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NCT Number: NCT03503214

Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

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.

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Key information

Conditions

Acid-Base Imbalance Acidosis Acidosis, Respiratory Alkalosis Alkalosis, Respiratory Hyperventilation Metabolic Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Acidosis Respiratory Alkalosis Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Septic patients and healthy volunteers

Exclusion criteria

  • age < 18 years and pregnancy

Treatment and study plan

In vitro determination of non-carbonic buffer power

Diagnostic Test

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

Diagnostic Test

Measurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach.

Primary outcomes

  1. Non-carbonic buffer power

    Time frame: 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 outcomes

  1. Strong Ion Difference variations induced by carbon dioxide

    Time frame: 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

  2. Bicarbonate Variations induced by carbon dioxide

    Time frame: 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

  3. Oxidized albumin

    Time frame: 1 day

    Oxidized albumin [expressed as percentage of total albumin concentration]

  4. Correlation between hematocrit values and Strong Ion Difference variations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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