SepsisENTERPRISENCT03966664
Determination of the Dissociation Constant (Ka) of Plasma and Whole Blood in Septic Patients
An observational study of Sepsis and Septic Shock, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Critical Illness
- What is being tested?
- In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma., In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood and Biomolecular analysis of plasma proteins.
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jun 2019to Jun 2021
- 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: 1. Patients with sepsis or septic shock admitted to the ICU 2. Healthy volunteers recruited from ICU staff members and relatives 3. Non-septic patients admitted to the ICU after elective surgery
Who may be able to join
- Diagnosis of Sepsis
- Age > 18 years
- Informed or deferred informed consent
- informed consent
- Age > 18 years
- Informed consent
- Age >18 years
- Planned ICU admission after elective surgery
Who cannot join
- Pregnancy
- Bilirubin > 4 mg/dL
- Minor or major thalassemia
- Transfusion of more than 4 Units of packed red blood cells and/or 1 L of plasma during the 24 hours prior to enrollment
- Group 2: Healthy volunteers
- Pregnancy
Show all 14Show fewer
- Group 3: Non-septic patients
- Diagnosis of sepsis
- Pregnancy
- Bilirubin >4 mg/dL
- Liver cirrhosis
- Onco-hematological diseases
- Minor or major thalassemia
- Transfusion of more than 4 Units of packed red blood cells and/or 1 L of plasma during the 24 hours prior to enrollment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
Third faculty of Medicine, Charles University of Prague
Prague
Frantisek Duska, MD, fduska@yahoo.it
Frantisek Duska, MD
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Thomas Langer, MD, 025503 ext. 3232, Thomas.Langer@unimi.it
Thomas Langer, MD
About this study
Official title: Determination of Ka of Isolated Plasma and Whole Blood of Critically Ill Patients With Sepsis, Non-septic Patients and Healthy Volunteers: an International, In-vitro Acid-base Study.
Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.
Read the detailed description
Acid-base equilibrium has been object of study for more than 100 years in medicine because of its relevance in patients' management and in determining their prognosis, especially in the ICU.
A concept closely related to acid-base equilibrium is that of "buffer", term used to define any substance able to limit the changes in pH caused by the addition or loss of alkali or acid.
Depending on its physiochemical features, every buffer has one or more pH (negative logarithm of hydrogen ion concentration) values where its ability to keep pH stable is maximal. These values are defined as Ka or semi equivalence points, i.e. the pH values where the buffer dissolved in solution is half in its associated form (AH) and half in its dissociated form (A-).
Several studies tried to determine the normal values of both concentration and Ka of ATOT. However, they did not lead to univocal results. Moreover, many of these values come from studies of veterinary medicine or are the result of theoretical estimates on human plasma.
Staempfli and Constable performed a single experimental study on human plasma in 2003. These authors, however, analyzed only isolated plasma, neglecting whole blood, and computed ATOT and Ka values of healthy volunteers, while Ka and ATOT values for critically ill patients with sepsis are still unknown.
Primary aim of the present study is to quantify the acidic dissociation constant (Ka) of isolated plasma of critically ill patients with sepsis, and compare these data with normal values, i.e. obtained from healthy controls. The investigators hypothesize that plasma of critically ill septic patients has a lower Ka and that, consequently, it undergoes higher pH variations for a given perturbation of the system (variation in carbon dioxide).
Secondary aim is to quantify the Ka of whole blood of critically ill patients with sepsis and compare these data with normal values, i.e. obtained from healthy controls. The investigators hypothesize that blood of critically ill septic patients has a lower Ka and that, consequently, it undergoes higher pH variations for a given perturbation of the system (variation in carbon dioxide).
Other aims of the study are:
- quantify the Ka of plasma and whole blood of non-septic patients admitted to the ICU and compare these results with the values of septic patients and healthy volunteers.
- define the normal concentration of weak non-carbonic acids (ATOT) in plasma of septic patients and compare it with data obtained in healthy volunteers and non-septic patients.
Finally, possible structural alteration of plasma proteins will be evaluated:
- Identification of differentially modified proteoforms of serum albumin and major plasma proteins by two-dimensional electrophoresis;
- High Performance Liquid Chromatography (HPLC) to identify different Redox-forms of albumin
- Spectrophotometric evaluation of modifications of ligand binding properties of serum albumin.
- Conditions
- Sepsis, Septic Shock, Critical Illness, Respiratory Acidosis, Respiratory Alkalosis, Acid-Base Imbalance
- Being tested
- In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma., In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood, Biomolecular analysis of plasma proteins.
- Keywords
- Acid-base equilibrium; pH; septic shock; critical illness
- Medical subject headings
- Sepsis, Shock, Septic, Critical Illness, Acidosis, Respiratory, Alkalosis, Respiratory, Acid-Base Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.Diagnostic test
Collection of a venous blood sample, centrifugation in order to harvest isolated plasma and performance of in-vitro tonometry in order to assess Ka and Atot.
In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole bloodDiagnostic test
Collection of a venous blood sample and performance of in-vitro tonometry in order to assess Ka and Atot.
Biomolecular analysis of plasma proteins.Diagnostic test
Bidimensional electrophoresis, determination of oxidized albumin fraction, characterization of altered ligand binding properties of plasma albumin.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Critically ill patients of both sexes admitted to the general ICU of the participating centers with the diagnosis of sepsis will be included. Receives: Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.; Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood; Diagnostic Test: Biomolecular analysis of plasma proteins. | |
| Healthy controls | Age and sex matched healthy volunteers. Receives: Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.; Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood; Diagnostic Test: Biomolecular analysis of plasma proteins. | |
| Non septic patients | Non-septic patients admitted to the general ICU of the participating centers after elective non-cardiac surgery. Receives: Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.; Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood; Diagnostic Test: Biomolecular analysis of plasma proteins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective dissociation constant of plasma weak acids (Ka) [dimensionless]
Difference in plasma Ka between study groups.
Measured: 1 day
Secondary outcomes (8)
Effective dissociation constant of whole blood weak acids (Ka) [dimensionless]
Difference in whole blood Ka between study groups.
Measured: 1 day
Total concentration of plasma non-volatile buffers (Atot) [mmol/L]
Difference in plasma Atot between study groups.
Measured: 1 day
Total concentration of whole blood non-volatile buffers (Atot) [mmol/L]
Difference in whole blood Atot between study groups.
Measured: 1 day
Non-carbonic buffer power of whole blood due to electrolyte shifts [milliequivalents/L]
Difference in Non-carbonic buffer power of whole blood due to electrolyte shifts between study groups.
Measured: 1 day
Non-carbonic buffer power of isolated plasma due to electrolyte shifts [milliequivalents/L]
Difference in Non-carbonic buffer power of isolated plasma due to electrolyte shifts between study groups.
Measured: 1 day
Oxidized albumin [%]
Difference in the percentage in oxidized albumin between groups.
Measured: 1 day
Characterization of altered ligand binding properties
HSA will be fractionated and dissociation constants for warfarin-SA and diazepam-SA complexes will be obtained spectrophotometrically to evaluate modifications in its ligand binding properties
Measured: 1 day
Identification of differentially modified proteoforms of human serum albumin (HSA) and major plasma proteins.
Samples will be analyzed by two-dimensional electrophoresis.8 After fluorescent staining and image acquisition, proteoform patterns corresponding to HSA and other major plasma proteins will be aligned and compared
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 posted29 May 2019
- Study start3 Jun 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Thomas Langer, MD, Principal investigator, Fondazione IRCCS Ca' Granda Hospital, Milano, ItalyAntonio M Pesenti, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoFrantisek Duska, MD, Principal investigator, Third faculty of Medicine, Charles University, PragueGiacomo Grasselli, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPaul Elbers, MD, Study chair, Amsterdam UMC, Department of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966664
- Sponsor's protocol ID
- ENTERPRISE
- Acronym
- ENTERPRISE
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Henderson LJ. THE REGULATION OF NEUTRALITY IN THE ANIMAL BODY. Science. 1913 Mar 14;37(950):389-95. doi: 10.1126/science.37.950.389. No abstract available.
PubMed 17795147Lee SW, Hong YS, Park DW, Choi SH, Moon SW, Park JS, Kim JY, Baek KJ. Lactic acidosis not hyperlactatemia as a predictor of in hospital mortality in septic emergency patients. Emerg Med J. 2008 Oct;25(10):659-65. doi: 10.1136/emj.2007.055558.
PubMed 18843064Fencl V, Leith DE. Stewart's quantitative acid-base chemistry: applications in biology and medicine. Respir Physiol. 1993 Jan;91(1):1-16. doi: 10.1016/0034-5687(93)90085-o.
PubMed 8441866LEEUWEN AM. NET CATION EQUIVALENCY ('BASE BINDING POWER') OF THE PLASMA PROTEINS. Acta Med Scand. 1964;176:SUPPL 422: 1+. No abstract available.
PubMed 14204741Figge J, Mydosh T, Fencl V. Serum proteins and acid-base equilibria: a follow-up. J Lab Clin Med. 1992 Nov;120(5):713-9.
PubMed 1431499Stampfli HR, Misiaszek S, Lumsden JH, Carlson GP, Heigenhauser GJ. Weak acid-concentration Atot and dissociation constant Ka of plasma proteins in racehorses. Equine Vet J Suppl. 1999 Jul;(30):438-42.
PubMed 10659296Staempfli HR, Constable PD. Experimental determination of net protein charge and A(tot) and K(a) of nonvolatile buffers in human plasma. J Appl Physiol (1985). 2003 Aug;95(2):620-30. doi: 10.1152/japplphysiol.00100.2003. Epub 2003 Mar 28.
PubMed 12665532Langer T, Scotti E, Carlesso E, Protti A, Zani L, Chierichetti M, Caironi P, Gattinoni L. Electrolyte shifts across the artificial lung in patients on extracorporeal membrane oxygenation: interdependence between partial pressure of carbon dioxide and strong ion difference. J Crit Care. 2015 Feb;30(1):2-6. doi: 10.1016/j.jcrc.2014.09.013. Epub 2014 Sep 22.
PubMed 25307980
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Ka of Isolated Plasma and Whole Blood of Critically Ill Patients With Sepsis, Non-septic Patients and Healthy Volunteers: an International, In-vitro Acid-base Study.
- ClinicalTrials.gov ID
- NCT03966664
- Acronym / sponsor ID
- ENTERPRISE / ENTERPRISE
- Conditions
- Sepsis, Septic Shock, Critical Illness, Respiratory Acidosis, Respiratory Alkalosis, Acid-Base Imbalance
- Keywords
- Acid-base equilibrium; pH; septic shock; critical illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 May 2019 (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.
Detailed description
Acid-base equilibrium has been object of study for more than 100 years in medicine because of its relevance in patients' management and in determining their prognosis, especially in the ICU.
A concept closely related to acid-base equilibrium is that of "buffer", term used to define any substance able to limit the changes in pH caused by the addition or loss of alkali or acid.
Depending on its physiochemical features, every buffer has one or more pH (negative logarithm of hydrogen ion concentration) values where its ability to keep pH stable is maximal. These values are defined as Ka or semi equivalence points, i.e. the pH values where the buffer dissolved in solution is half in its associated form (AH) and half in its dissociated form (A-).
Several studies tried to determine the normal values of both concentration and Ka of ATOT. However, they did not lead to univocal results. Moreover, many of these values come from studies of veterinary medicine or are the result of theoretical estimates on human plasma.
Staempfli and Constable performed a single experimental study on human plasma in 2003. These authors, however, analyzed only isolated plasma, neglecting whole blood, and computed ATOT and Ka values of healthy volunteers, while Ka and ATOT values for critically ill patients with sepsis are still unknown.
Primary aim of the present study is to quantify the acidic dissociation constant (Ka) of isolated plasma of critically ill patients with sepsis, and compare these data with normal values, i.e. obtained from healthy controls. The investigators hypothesize that plasma of critically ill septic patients has a lower Ka and that, consequently, it undergoes higher pH variations for a given perturbation of the system (variation in carbon dioxide).
Secondary aim is to quantify the Ka of whole blood of critically ill patients with sepsis and compare these data with normal values, i.e. obtained from healthy controls. The investigators hypothesize that blood of critically ill septic patients has a lower Ka and that, consequently, it undergoes higher pH variations for a given perturbation of the system (variation in carbon dioxide).
Other aims of the study are:
- quantify the Ka of plasma and whole blood of non-septic patients admitted to the ICU and compare these results with the values of septic patients and healthy volunteers.
- define the normal concentration of weak non-carbonic acids (ATOT) in plasma of septic patients and compare it with data obtained in healthy volunteers and non-septic patients.
Finally, possible structural alteration of plasma proteins will be evaluated:
- Identification of differentially modified proteoforms of serum albumin and major plasma proteins by two-dimensional electrophoresis;
- High Performance Liquid Chromatography (HPLC) to identify different Redox-forms of albumin
- Spectrophotometric evaluation of modifications of ligand binding properties of serum albumin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Septic patients | – | Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma., Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood, Diagnostic Test: Biomolecular analysis of plasma proteins.Critically ill patients of both sexes admitted to the general ICU of the participating centers with the diagnosis of sepsis will be included. |
| Healthy controls | – | Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma., Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood, Diagnostic Test: Biomolecular analysis of plasma proteins.Age and sex matched healthy volunteers. |
| Non septic patients | – | Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma., Diagnostic Test: In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood, Diagnostic Test: Biomolecular analysis of plasma proteins.Non-septic patients admitted to the general ICU of the participating centers after elective non-cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with sepsis or septic shock admitted to the ICU 2. Healthy volunteers recruited from ICU staff members and relatives 3. Non-septic patients admitted to the ICU after elective surgery
Key inclusion criteria (8 listed)
- Diagnosis of Sepsis
- Age > 18 years
- Informed or deferred informed consent
- informed consent
- Age > 18 years
Key exclusion criteria (14 listed)
- Pregnancy
- Bilirubin > 4 mg/dL
- Minor or major thalassemia
- Transfusion of more than 4 Units of packed red blood cells and/or 1 L of plasma during the 24 hours prior to enrollment
- Group 2: Healthy volunteers
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 the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.Collection of a venous blood sample, centrifugation in order to harvest isolated plasma and performance of in-vitro tonometry in order to assess Ka and Atot. | Diagnostic test | Healthy controls, Non septic patients, Septic patients |
| In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole bloodCollection of a venous blood sample and performance of in-vitro tonometry in order to assess Ka and Atot. | Diagnostic test | Healthy controls, Non septic patients, Septic patients |
| Biomolecular analysis of plasma proteins.Bidimensional electrophoresis, determination of oxidized albumin fraction, characterization of altered ligand binding properties of plasma albumin. | Diagnostic test | Healthy controls, Non septic patients, Septic patients |
Primary outcome
Effective dissociation constant of plasma weak acids (Ka) [dimensionless]
Time frame: 1 day
Difference in plasma Ka between study groups.
8 secondary outcomes
Effective dissociation constant of whole blood weak acids (Ka) [dimensionless]
Time frame: 1 day
Total concentration of plasma non-volatile buffers (Atot) [mmol/L]
Time frame: 1 day
Total concentration of whole blood non-volatile buffers (Atot) [mmol/L]
Time frame: 1 day
Non-carbonic buffer power of whole blood due to electrolyte shifts [milliequivalents/L]
Time frame: 1 day
Non-carbonic buffer power of isolated plasma due to electrolyte shifts [milliequivalents/L]
Time frame: 1 day
Oxidized albumin [%]
Time frame: 1 day
Characterization of altered ligand binding properties
Time frame: 1 day
Identification of differentially modified proteoforms of human serum albumin (HSA) and major plasma proteins.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 17795147Henderson LJ. THE REGULATION OF NEUTRALITY IN THE ANIMAL BODY. Science. 1913 Mar 14;37(950):389-95. doi: 10.1126/science.37.950.389. No abstract available.
- Background: PubMed 18843064Lee SW, Hong YS, Park DW, Choi SH, Moon SW, Park JS, Kim JY, Baek KJ. Lactic acidosis not hyperlactatemia as a predictor of in hospital mortality in septic emergency patients. Emerg Med J. 2008 Oct;25(10):659-65. doi: 10.1136/emj.2007.055558.
- Background: PubMed 8441866Fencl V, Leith DE. Stewart's quantitative acid-base chemistry: applications in biology and medicine. Respir Physiol. 1993 Jan;91(1):1-16. doi: 10.1016/0034-5687(93)90085-o.
- Background: PubMed 14204741LEEUWEN AM. NET CATION EQUIVALENCY ('BASE BINDING POWER') OF THE PLASMA PROTEINS. Acta Med Scand. 1964;176:SUPPL 422: 1+. No abstract available.
- Background: PubMed 1431499Figge J, Mydosh T, Fencl V. Serum proteins and acid-base equilibria: a follow-up. J Lab Clin Med. 1992 Nov;120(5):713-9.
- Background: PubMed 10659296Stampfli HR, Misiaszek S, Lumsden JH, Carlson GP, Heigenhauser GJ. Weak acid-concentration Atot and dissociation constant Ka of plasma proteins in racehorses. Equine Vet J Suppl. 1999 Jul;(30):438-42.
- Background: PubMed 12665532Staempfli HR, Constable PD. Experimental determination of net protein charge and A(tot) and K(a) of nonvolatile buffers in human plasma. J Appl Physiol (1985). 2003 Aug;95(2):620-30. doi: 10.1152/japplphysiol.00100.2003. Epub 2003 Mar 28.
- Background: PubMed 25307980Langer T, Scotti E, Carlesso E, Protti A, Zani L, Chierichetti M, Caironi P, Gattinoni L. Electrolyte shifts across the artificial lung in patients on extracorporeal membrane oxygenation: interdependence between partial pressure of carbon dioxide and strong ion difference. J Crit Care. 2015 Feb;30(1):2-6. doi: 10.1016/j.jcrc.2014.09.013. Epub 2014 Sep 22.
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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 Hospital, Milano, Italy
Antonio M Pesenti, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Frantisek Duska, MD principal investigator
Third faculty of Medicine, Charles University, Prague
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in 2 countries.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Langer, MD (0255033232, thomas.langer@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dissociation constant of plasma weak acids (Ka) [dimensionless] (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966664, which also lists 8 linked publications.
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 4 Jun 2019.