NCT03503214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

April 25, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

April 9, 2018

Last Update Submit

April 24, 2019

Conditions

Acid-Base ImbalanceRespiratory AcidosisRespiratory Alkalosis

Keywords

Acid-base equilibriumStewart's approachIn vitro studyRespiratory acid-base derangements

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Strong Ion Difference variations induced by carbon dioxide

    1 day

  • Bicarbonate Variations induced by carbon dioxide

    1 day

  • Oxidized albumin

    1 day

  • Correlation between hematocrit values and Strong Ion Difference variations

    1 day

Study Arms (2)

Septic patients

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

Diagnostic Test: In vitro determination of non-carbonic buffer powerDiagnostic Test: Classic description of acid-base status

Healthy volunteers

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

Diagnostic Test: In vitro determination of non-carbonic buffer powerDiagnostic Test: Classic description of acid-base status

Interventions

In vitro determination of non-carbonic buffer powerDIAGNOSTIC_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

Healthy volunteersSeptic patients
Classic description of acid-base statusDIAGNOSTIC_TEST

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

Healthy volunteersSeptic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Septic patients and healthy volunteers

You may not qualify if:

  • age \< 18 years and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Acid-Base ImbalanceAcidosis, RespiratoryAlkalosis, Respiratory

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesAcidosisHyperventilationAlkalosis

Study Officials

  • Thomas Langer, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

    PRINCIPAL INVESTIGATOR

  • Antonio Pesenti, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

    STUDY DIRECTOR

  • Giacomo Grasselli, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 19, 2018

Study Start

March 7, 2018

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

April 25, 2019

Record last verified: 2019-03

Locations

IT(1)