NCT06908408

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

January 11, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 22, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

metabolic acidosis severityBErelative platelet count decline in critically illbase excessplatelet count decline in critically ill

Outcome Measures

Primary Outcomes (1)

  • 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 %).

    From admission to the ICU (base line) and 2 days following admission

Interventions

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.

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Admitted to the ICU department in a 1 year period (from 1st January to 31th December 2020)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Zaloška cesta 7, 1000 Ljubljana, Slovenia

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (14)

  • 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.

    PMID: 29653154BACKGROUND
  • Demiselle 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.

    PMID: 30225670BACKGROUND
  • Roberts 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.

    PMID: 29437118BACKGROUND
  • Geers 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.

    PMID: 10747205BACKGROUND
  • Park 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.

    PMID: 38375495BACKGROUND
  • Scardina P, Edwards M. Prediction and measurement of bubble formation in water treatment. Journal of Environmental Engineering 2001 Nov;127:968-973.

    BACKGROUND
  • 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.

    PMID: 19070304BACKGROUND
  • Pontier 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.

    PMID: 18717114BACKGROUND
  • Levi M, Opal SM. Coagulation abnormalities in critically ill patients. Crit Care. 2006;10(4):222. doi: 10.1186/cc4975.

    PMID: 16879728BACKGROUND
  • Ilker 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
  • 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.

    PMID: 10890635BACKGROUND
  • Wang 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.

    PMID: 34805203BACKGROUND
  • Lee 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.

    PMID: 32975059BACKGROUND
  • Moreau 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.

    PMID: 17475637BACKGROUND

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Primož Gradišek, MD, PhD, Prof.

    Department of Anaesthesiology and Surgical Intensive Care

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2025

First Posted

April 3, 2025

Study Start

January 11, 2024

Primary Completion

February 11, 2024

Study Completion

February 14, 2024

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Beginning with publication of results with no end date.
Access Criteria
After publication of results all IPD data of the study can be shared on request on email of investigator: irena.grad@gmail.com

Locations