Acid-Base ImbalanceNCT03503214
Non Carbonic Buffer Power of Critical Ill Patients With Sepsis
An observational study of Acid-Base Imbalance and Respiratory Acidosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acid-Base Imbalance, Respiratory Acidosis, Respiratory Alkalosis
- What is being tested?
- In vitro determination of non-carbonic buffer power and Classic description of acid-base status
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2018to 20 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Septic patients and healthy volunteers
Who cannot join
- age < 18 years and pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
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
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.
Read the 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.
- Being tested
- In vitro determination of non-carbonic buffer power, Classic description of acid-base status
- Keywords
- Acid-base equilibrium, Stewart's approach, In vitro study, Respiratory acid-base derangements
- Medical subject headings
- Acid-Base Imbalance, Acidosis, Respiratory, Alkalosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Patients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit Receives: Diagnostic Test: In vitro determination of non-carbonic buffer power; Diagnostic Test: Classic description of acid-base status | |
| Healthy volunteers | Subjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases. Receives: Diagnostic Test: In vitro determination of non-carbonic buffer power; Diagnostic Test: Classic description of acid-base status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (4)
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
Measured: 1 day
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
Measured: 1 day
Oxidized albumin
Oxidized albumin [expressed as percentage of total albumin concentration]
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start7 Mar 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid-Base ImbalanceStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Langer, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di MilanoAntonio Pesenti, MD, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di MilanoGiacomo Grasselli, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503214
- Sponsor's protocol ID
- Buffer power
- Status last verified
- Mar 2019
- First submitted
- 9 Apr 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03503214
- Acronym / sponsor ID
- Buffer power
- Keywords
- Acid-base equilibrium, Stewart's approach, In vitro study, Respiratory acid-base derangements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic patients | – | Diagnostic Test: In vitro determination of non-carbonic buffer power, Diagnostic Test: Classic description of acid-base statusPatients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit |
| Healthy volunteers | – | Diagnostic Test: In vitro determination of non-carbonic buffer power, Diagnostic Test: Classic description of acid-base statusSubjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Septic patients and healthy volunteers
Key exclusion criteria (1 listed)
- age < 18 years and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro determination of non-carbonic buffer powerIn 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 | Diagnostic test | Healthy volunteers, Septic patients |
| Classic description of acid-base statusMeasurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach. | Diagnostic test | Healthy volunteers, Septic patients |
Primary outcome
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).
4 secondary outcomes
Strong Ion Difference variations induced by carbon dioxide
Time frame: 1 day
Bicarbonate Variations induced by carbon dioxide
Time frame: 1 day
Oxidized albumin
Time frame: 1 day
Correlation between hematocrit values and Strong Ion Difference variations
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Langer, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Antonio Pesenti, MD study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Giacomo Grasselli, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acid-Base Imbalance and Respiratory Acidosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-carbonic buffer power (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.