Sepsis Clinical Trial
— ENTERPRISEOfficial 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.
NCT number | NCT03966664 |
Other study ID # | ENTERPRISE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 3, 2019 |
Est. completion date | June 2021 |
Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Group 1: Septic patients Inclusion Criteria for Group 1: - Diagnosis of Sepsis - Age > 18 years - Informed or deferred informed consent Exclusion Criteria for Group 1: - 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 Inclusion criteria for Group 2: - informed consent - Age > 18 years Exclusion criteria for Group 2: • Pregnancy Group 3: Non-septic patients Inclusion criteria for Group 3: - Informed consent - Age >18 years - Planned ICU admission after elective surgery Exclusion criteria for Group 3: - 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Third faculty of Medicine, Charles University of Prague | Prague | |
Italy | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Charles University, Czech Republic |
Czechia, Italy,
Fencl V, Leith DE. Stewart's quantitative acid-base chemistry: applications in biology and medicine. Respir Physiol. 1993 Jan;91(1):1-16. Review. — View Citation
Figge J, Mydosh T, Fencl V. Serum proteins and acid-base equilibria: a follow-up. J Lab Clin Med. 1992 Nov;120(5):713-9. — View Citation
Henderson LJ. THE REGULATION OF NEUTRALITY IN THE ANIMAL BODY. Science. 1913 Mar 14;37(950):389-95. — View Citation
Langer 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. — View Citation
Lee 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. — View Citation
LEEUWEN AM. NET CATION EQUIVALENCY ('BASE BINDING POWER') OF THE PLASMA PROTEINS. Acta Med Scand. 1964;176:SUPPL 422: 1+. — View Citation
Staempfli 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. Epub 2003 Mar 28. — View Citation
Stampfli 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effective dissociation constant of plasma weak acids (Ka) [dimensionless] | Difference in plasma Ka between study groups. | 1 day | |
Secondary | Effective dissociation constant of whole blood weak acids (Ka) [dimensionless] | Difference in whole blood Ka between study groups. | 1 day | |
Secondary | Total concentration of plasma non-volatile buffers (Atot) [mmol/L] | Difference in plasma Atot between study groups. | 1 day | |
Secondary | Total concentration of whole blood non-volatile buffers (Atot) [mmol/L] | Difference in whole blood Atot between study groups. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | Oxidized albumin [%] | Difference in the percentage in oxidized albumin between groups. | 1 day | |
Secondary | 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 | 1 day | |
Secondary | 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 | 1 day |
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