Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

NCT ID: NCT03503214

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-02-20

Brief Summary

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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

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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.

Conditions

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Acid-Base Imbalance Respiratory Acidosis Respiratory Alkalosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic patients

Patients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit

In vitro determination of non-carbonic buffer power

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Healthy volunteers

Subjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases.

In vitro determination of non-carbonic buffer power

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Septic patients and healthy volunteers

Exclusion Criteria

* age \< 18 years and pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Langer, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Antonio Pesenti, MD

Role: STUDY_DIRECTOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Giacomo Grasselli, MD

Role: STUDY_CHAIR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Locations

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IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Buffer power

Identifier Type: -

Identifier Source: org_study_id

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