Platelet Count Decline in Critically IllBE-PlateletNCT06908408
Correlation Between Base Excess in Patients Upon Admission to the ICU and Platelet Count Trend in the Following Days
An observational study of Platelet Count Decline in Critically Ill and Metabolic Acidosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Several studies have revealed that a relative platelet count decline in patients after their admission to the intensive care unit (ICU) is a very reliable marker of the severity of their sickness. ICU patients with a greater platelet count decline after their admission to the ICU have generally worse outcome. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Platelet Count Decline in Critically Ill, Metabolic Acidosis, Metabolic Acidosis Severity
- What is being tested?
- Corrrelation between metabolic acidosis severity in patients on admission to the ICU and platelet count trend in 2 days following admission was investigated
- How many people
- 484 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 Jan 2024to 14 Feb 2024
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study has been conducted at the Department of Anaesthesiology and Surgical Intensive Care at University Medical Centre Ljubljana. All participants, admitted to the ICU of Department of Anaesthesiology and Surgical Intensive Care in 2020 were included.
Who may be able to join
- Admitted to the ICU department in a 1 year period (from 1st January to 31th December 2020)
Who cannot join
- Lacking blood gas analysis data on admission
- Incomplete platelet count data (lacking platelet count on admission to the ICU and day 2 after the admission)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Ljubljana, Zaloška cesta 7, 1000 Ljubljana, Slovenia
Ljubljana, Slovenia, 1000
About this study
Official title: Correlation Between the Severity of Metabolic Acidosis in Patients on Admission to the ICU and Platelet Count Trend in the Following Days
Several studies have revealed that a relative platelet count decline in patients after their admission to the intensive care unit (ICU) is a very reliable marker of the severity of their sickness. ICU patients with a greater platelet count decline after their admission to the ICU have generally worse outcome. Investigators assume that a quick appearance of a deep metabolic acidosis, which commonly occurs in critically ill, has an important role in pathogenesis of relative platelet count decline. To evaluate this, correlation of metabolic acidosis severity in participants upon admission to the ICU with platelet count decline in 2 days, following admission, was investigated with a retrospective observational study, analysing all participants, admitted to the ICU in one year period (in 2020).
As a measurement of metabolic acidosis severity, investigators took base excess (BE) value (expressed in mmol/L) from arterial blood gas analysis with lowest pH in participants in around admission time (in a period from 24 hours before to 24 hours after their admission to the ICU). To calculate relative platelet count decline in 2 days after admission to the ICU, investigators took platelet count on admission to the ICU (P0) and lowest platelet count on day 2 after the patient's admission (P2). Following formula was used to calculate relative platelet count decline in 2 days after ICU admission (delta P): delta P = (P2-P0)/P0 x 100 (expressed in %). More negative values of delta P represent larger relative platelet count decline.
Read more
The main interest of the study was if BE value correlates with delta P. Investigators assumed that participants with a more severe metabolic acidosis upon admission to the ICU (represented with more negative BE value) would tend to have a larger relative platelet count decline in 2 days, following admission to the ICU (represented with more negative value of delta P).
Pearson correlation was used to evaluate correlation between BE and delta P.
Read the detailed description
The aim of the study was to answer the question, if metabolic acidosis severity in participants upon admission to the ICU correlatets with platelet count decline in days, following admission.
Investigators conducted this study at the Department of Anesthesiology and Surgical Intensive Care at University Medical Centre Ljubljana. The study included all participants, admitted to the ICU in a one-year period (in 2020; from 1st January to 31st December 2020). From the electronic recordings of the department (Hospital Information System BIRPIS21), investigators obtained the following data of each participant: age, gender, lowest pH in arterial blood gas analysis in around admission time with corresponding bicarbonate concentration [HCO3-] and BE value, platelet count on admission (P0), and lowest platelet count on second day after ICU admission (P2).
As a measurement of metabolic acidosis severity, investigators took the BE value of arterial blood gas analysis with the lowest pH from the range of 24 hours before to 24 hours after ICU admission. To calculate relative platelet count decline in 2 days after ICU admission (delta P), the following formula was used: delta P = (P2-P0)/P0 x 100.
Participants who died before the second day after ICU admission or participants whose demanded laboratory findings were for some other reasons lacking (arterial blood gas analysis or platelet count on admission or platelet count on second day after ICU admission), were excluded from final analysis of correlation between BE and delta P.
Pearson's correlation coefficient (r) with 95% confidence interval (CI) was used to estimate the association between BE and delta P.
- Conditions
- Platelet Count Decline in Critically Ill, Metabolic Acidosis, Metabolic Acidosis Severity, Platelet Count Decline in ICU Patients
- Being tested
- Corrrelation between metabolic acidosis severity in patients on admission to the ICU and platelet count trend in 2 days following admission was investigated
- Keywords
- metabolic acidosis severity, BE, relative platelet count decline in critically ill, base excess, platelet count decline in critically ill
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrrelation between metabolic acidosis severity in patients on admission to the ICU and platelet count trend in 2 days following admission was investigatedDiagnostic test
The aim of the study was to investigate if there exists any correlation between metabolic acidosis severity in patients upon admission to the ICU and platelet count trend in 2 days, following admission.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative platelet count decline in participants from admission to the ICU to their second day after ICU admission
In this observational study relative platelet count decline in participants from admission to the ICU to their second day after the admission to the ICU was measured (with the aim to analyse correlation between metabolic acidosis severity in participants upon admission to the ICU and platelet count trend in participants in the following 2 days).
Platelet count value in participants upon admission to the ICU (P0) and lowest platelet count value on day 2 after the admission to the ICU (P2) were used to calculate relative platelet count decline in 2 days after ICU admission (delta P), using formula: delta P = (P2-P0)/P0 x 100 (delta P expressed in %).
Measured: From admission to the ICU (base line) and 2 days following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start11 Jan 2024
- Primary completion11 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Platelet Count Decline in Critically IllStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irena Grad, University Medical Centre Ljubljana
- Investigators
- Primož Gradišek, MD, PhD, Prof., Study chair, Department of Anaesthesiology and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908408
- Sponsor's protocol ID
- UMCLj-BE-Platelet
- Other IDs
- Irena Grad
- Acronym
- BE-Platelet
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Patel JK, Kataya A, Parikh PB. Association between intra- and post-arrest hyperoxia on mortality in adults with cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2018 Jun;127:83-88. doi: 10.1016/j.resuscitation.2018.04.008. Epub 2018 Apr 10.
PubMed 29653154Demiselle J, Wepler M, Hartmann C, Radermacher P, Schortgen F, Meziani F, Singer M, Seegers V, Asfar P; HYPER2S investigators. Hyperoxia toxicity in septic shock patients according to the Sepsis-3 criteria: a post hoc analysis of the HYPER2S trial. Ann Intensive Care. 2018 Sep 17;8(1):90. doi: 10.1186/s13613-018-0435-1.
PubMed 30225670Roberts BW, Kilgannon JH, Hunter BR, Puskarich MA, Pierce L, Donnino M, Leary M, Kline JA, Jones AE, Shapiro NI, Abella BS, Trzeciak S. Association Between Early Hyperoxia Exposure After Resuscitation From Cardiac Arrest and Neurological Disability: Prospective Multicenter Protocol-Directed Cohort Study. Circulation. 2018 May 15;137(20):2114-2124. doi: 10.1161/CIRCULATIONAHA.117.032054. Epub 2018 Feb 1.
PubMed 29437118Geers C, Gros G. Carbon dioxide transport and carbonic anhydrase in blood and muscle. Physiol Rev. 2000 Apr;80(2):681-715. doi: 10.1152/physrev.2000.80.2.681.
PubMed 10747205Park MAJ, Cave G, Freebairn RC. Metabolic acidosis in anaesthesia and critical care. BJA Educ. 2024 Mar;24(3):91-99. doi: 10.1016/j.bjae.2023.12.005. Epub 2024 Jan 22. No abstract available.
PubMed 38375495Scardina P, Edwards M. Prediction and measurement of bubble formation in water treatment. Journal of Environmental Engineering 2001 Nov;127:968-973.
Pontier JM, Jimenez C, Blatteau JE. Blood platelet count and bubble formation after a dive to 30 msw for 30 min. Aviat Space Environ Med. 2008 Dec;79(12):1096-9. doi: 10.3357/asem.2352.2008.
PubMed 19070304Pontier JM, Blatteau JE, Vallee N. Blood platelet count and severity of decompression sickness in rats after a provocative dive. Aviat Space Environ Med. 2008 Aug;79(8):761-4. doi: 10.3357/asem.2299.2008.
PubMed 18717114Levi M, Opal SM. Coagulation abnormalities in critically ill patients. Crit Care. 2006;10(4):222. doi: 10.1186/cc4975.
PubMed 16879728Ilker Hayiroglu M, Cinar T, Ilker Tekkesin A. Intra-aortic balloon pump-related thrombocytopenia: Its effects on in-hospital mortality in cardiogenic shock patients. Annals Med Res 2021;26(7):1388-93.
Vanderschueren S, De Weerdt A, Malbrain M, Vankersschaever D, Frans E, Wilmer A, Bobbaers H. Thrombocytopenia and prognosis in intensive care. Crit Care Med. 2000 Jun;28(6):1871-6. doi: 10.1097/00003246-200006000-00031.
PubMed 10890635Wang L, Shao J, Shao C, Wang H, Jia M, Hou X. The Relative Early Decrease in Platelet Count Is Associated With Mortality in Post-cardiotomy Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. Front Med (Lausanne). 2021 Nov 4;8:733946. doi: 10.3389/fmed.2021.733946. eCollection 2021.
PubMed 34805203Lee HH, Hong SJ, Ahn CM, Yang JH, Gwon HC, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y. Clinical Implications of Thrombocytopenia at Cardiogenic Shock Presentation: Data from a Multicenter Registry. Yonsei Med J. 2020 Oct;61(10):851-859. doi: 10.3349/ymj.2020.61.10.851.
PubMed 32975059Moreau D, Timsit JF, Vesin A, Garrouste-Orgeas M, de Lassence A, Zahar JR, Adrie C, Vincent F, Cohen Y, Schlemmer B, Azoulay E. Platelet count decline: an early prognostic marker in critically ill patients with prolonged ICU stays. Chest. 2007 Jun;131(6):1735-41. doi: 10.1378/chest.06-2233. Epub 2007 May 2.
PubMed 17475637
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Severity of Metabolic Acidosis in Patients on Admission to the ICU and Platelet Count Trend in the Following Days
- ClinicalTrials.gov ID
- NCT06908408
- Acronym / sponsor ID
- BE-Platelet / UMCLj-BE-Platelet
- Conditions
- Platelet Count Decline in Critically Ill, Metabolic Acidosis, Metabolic Acidosis Severity, Platelet Count Decline in ICU Patients
- Keywords
- metabolic acidosis severity, BE, relative platelet count decline in critically ill, base excess, platelet count decline in critically ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 3 Apr 2025 (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.
Several studies have revealed that a relative platelet count decline in patients after their admission to the intensive care unit (ICU) is a very reliable marker of the severity of their sickness. ICU patients with a greater platelet count decline after their admission to the ICU have generally worse outcome. Investigators assume that a quick appearance of a deep metabolic acidosis, which commonly occurs in critically ill, has an important role in pathogenesis of relative platelet count decline. To evaluate this, correlation of metabolic acidosis severity in participants upon admission to the ICU with platelet count decline in 2 days, following admission, was investigated with a retrospective observational study, analysing all participants, admitted to the ICU in one year period (in 2020).
As a measurement of metabolic acidosis severity, investigators took base excess (BE) value (expressed in mmol/L) from arterial blood gas analysis with lowest pH in participants in around admission time (in a period from 24 hours before to 24 hours after their admission to the ICU). To calculate relative platelet count decline in 2 days after admission to the ICU, investigators took platelet count on admission to the ICU (P0) and lowest platelet count on day 2 after the patient's admission (P2). Following formula was used to calculate relative platelet count decline in 2 days after ICU admission (delta P): delta P = (P2-P0)/P0 x 100 (expressed in %). More negative values of delta P represent larger relative platelet count decline.
The main interest of the study was if BE value correlates with delta P. Investigators assumed that participants with a more severe metabolic acidosis upon admission to the ICU (represented with more negative BE value) would tend to have a larger relative platelet count decline in 2 days, following admission to the ICU (represented with more negative value of delta P).
Pearson correlation was used to evaluate correlation between BE and delta P.
Detailed description
The aim of the study was to answer the question, if metabolic acidosis severity in participants upon admission to the ICU correlatets with platelet count decline in days, following admission.
Investigators conducted this study at the Department of Anesthesiology and Surgical Intensive Care at University Medical Centre Ljubljana. The study included all participants, admitted to the ICU in a one-year period (in 2020; from 1st January to 31st December 2020). From the electronic recordings of the department (Hospital Information System BIRPIS21), investigators obtained the following data of each participant: age, gender, lowest pH in arterial blood gas analysis in around admission time with corresponding bicarbonate concentration [HCO3-] and BE value, platelet count on admission (P0), and lowest platelet count on second day after ICU admission (P2).
As a measurement of metabolic acidosis severity, investigators took the BE value of arterial blood gas analysis with the lowest pH from the range of 24 hours before to 24 hours after ICU admission. To calculate relative platelet count decline in 2 days after ICU admission (delta P), the following formula was used: delta P = (P2-P0)/P0 x 100.
Participants who died before the second day after ICU admission or participants whose demanded laboratory findings were for some other reasons lacking (arterial blood gas analysis or platelet count on admission or platelet count on second day after ICU admission), were excluded from final analysis of correlation between BE and delta P.
Pearson's correlation coefficient (r) with 95% confidence interval (CI) was used to estimate the association between BE and delta P.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study has been conducted at the Department of Anaesthesiology and Surgical Intensive Care at University Medical Centre Ljubljana. All participants, admitted to the ICU of Department of Anaesthesiology and Surgical Intensive Care in 2020 were included.
Key inclusion criteria (1 listed)
- Admitted to the ICU department in a 1 year period (from 1st January to 31th December 2020)
Key exclusion criteria (2 listed)
- Lacking blood gas analysis data on admission
- Incomplete platelet count data (lacking platelet count on admission to the ICU and day 2 after the admission)
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 |
|---|---|---|
| Corrrelation between metabolic acidosis severity in patients on admission to the ICU and platelet count trend in 2 days following admission was investigatedThe aim of the study was to investigate if there exists any correlation between metabolic acidosis severity in patients upon admission to the ICU and platelet count trend in 2 days, following admission. | Diagnostic test | – |
Primary outcome
Relative platelet count decline in participants from admission to the ICU to their second day after ICU admission
Time frame: From admission to the ICU (base line) and 2 days following admission
In this observational study relative platelet count decline in participants from admission to the ICU to their second day after the admission to the ICU was measured (with the aim to analyse correlation between metabolic acidosis severity in participants upon admission to the ICU and platelet count trend in participants in the following 2 days). Platelet count value in participants upon admission to the ICU (P0) and lowest platelet count value on day 2 after the admission to the ICU (P2) were used to calculate relative platelet count decline in 2 days after ICU admission (delta P), using formula: delta P = (P2-P0)/P0 x 100 (delta P expressed in %).
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 3 Apr 2025.
- Background: PubMed 29653154Patel JK, Kataya A, Parikh PB. Association between intra- and post-arrest hyperoxia on mortality in adults with cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2018 Jun;127:83-88. doi: 10.1016/j.resuscitation.2018.04.008. Epub 2018 Apr 10.
- Background: PubMed 30225670Demiselle J, Wepler M, Hartmann C, Radermacher P, Schortgen F, Meziani F, Singer M, Seegers V, Asfar P; HYPER2S investigators. Hyperoxia toxicity in septic shock patients according to the Sepsis-3 criteria: a post hoc analysis of the HYPER2S trial. Ann Intensive Care. 2018 Sep 17;8(1):90. doi: 10.1186/s13613-018-0435-1.
- Background: PubMed 29437118Roberts BW, Kilgannon JH, Hunter BR, Puskarich MA, Pierce L, Donnino M, Leary M, Kline JA, Jones AE, Shapiro NI, Abella BS, Trzeciak S. Association Between Early Hyperoxia Exposure After Resuscitation From Cardiac Arrest and Neurological Disability: Prospective Multicenter Protocol-Directed Cohort Study. Circulation. 2018 May 15;137(20):2114-2124. doi: 10.1161/CIRCULATIONAHA.117.032054. Epub 2018 Feb 1.
- Background: PubMed 10747205Geers C, Gros G. Carbon dioxide transport and carbonic anhydrase in blood and muscle. Physiol Rev. 2000 Apr;80(2):681-715. doi: 10.1152/physrev.2000.80.2.681.
- Background: PubMed 38375495Park MAJ, Cave G, Freebairn RC. Metabolic acidosis in anaesthesia and critical care. BJA Educ. 2024 Mar;24(3):91-99. doi: 10.1016/j.bjae.2023.12.005. Epub 2024 Jan 22. No abstract available.
- BackgroundScardina P, Edwards M. Prediction and measurement of bubble formation in water treatment. Journal of Environmental Engineering 2001 Nov;127:968-973.
- Background: PubMed 19070304Pontier JM, Jimenez C, Blatteau JE. Blood platelet count and bubble formation after a dive to 30 msw for 30 min. Aviat Space Environ Med. 2008 Dec;79(12):1096-9. doi: 10.3357/asem.2352.2008.
- Background: PubMed 18717114Pontier JM, Blatteau JE, Vallee N. Blood platelet count and severity of decompression sickness in rats after a provocative dive. Aviat Space Environ Med. 2008 Aug;79(8):761-4. doi: 10.3357/asem.2299.2008.
- Background: PubMed 16879728Levi M, Opal SM. Coagulation abnormalities in critically ill patients. Crit Care. 2006;10(4):222. doi: 10.1186/cc4975.
- BackgroundIlker Hayiroglu M, Cinar T, Ilker Tekkesin A. Intra-aortic balloon pump-related thrombocytopenia: Its effects on in-hospital mortality in cardiogenic shock patients. Annals Med Res 2021;26(7):1388-93.
- Background: PubMed 10890635Vanderschueren S, De Weerdt A, Malbrain M, Vankersschaever D, Frans E, Wilmer A, Bobbaers H. Thrombocytopenia and prognosis in intensive care. Crit Care Med. 2000 Jun;28(6):1871-6. doi: 10.1097/00003246-200006000-00031.
- Background: PubMed 34805203Wang L, Shao J, Shao C, Wang H, Jia M, Hou X. The Relative Early Decrease in Platelet Count Is Associated With Mortality in Post-cardiotomy Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. Front Med (Lausanne). 2021 Nov 4;8:733946. doi: 10.3389/fmed.2021.733946. eCollection 2021.
- Individual participant dataSharing planned: Yes. All collected IPD
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.
Primož Gradišek, MD, PhD, Prof. study chair
Department of Anaesthesiology and Surgical Intensive Care
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 Platelet Count Decline in Critically Ill and Metabolic Acidosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 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 3 Apr 2025. 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 Slovenia. 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?
Relative platelet count decline in participants from admission to the ICU to their second day after ICU admission (time frame: From admission to the ICU (base line) and 2 days following admission). 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 NCT06908408, which also lists 14 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 3 Apr 2025.