Sepsis Clinical Trial
— DISSIPATEOfficial title:
DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study)
NCT number | NCT04624945 |
Other study ID # | 2020/00020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2020 |
Est. completion date | December 2024 |
The research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome (SIRS).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: - Adults 21 years and above - Clinical/radiological suspicion or confirmation of neurological haemorrhage Exclusion Criteria: - Age below 21 years - Prisoners - Known pregnancy - Do-not-attempt resuscitation status - Requirement for immediate surgery - Active chemotherapy/neutropenia (Neutrophil count <1.0 x 109/L) - Immuno-compromised - Haematological malignancy - Treating physician deems aggressive care unsuitable - Unable to provide informed consent or comply with study requirements |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital, Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | Sysmex Asia Pacific Pte Ltd |
Singapore,
Chopin N, Floccard B, Sobas F, Illinger J, Boselli E, Benatir F, Levrat A, Guillaume C, Crozon J, Negrier C, Allaouchiche B. Activated partial thromboplastin time waveform analysis: a new tool to detect infection? Crit Care Med. 2006 Jun;34(6):1654-60. doi: 10.1097/01.CCM.0000217471.12799.1C. — View Citation
Jang JH, Park WB, Lim YS, Choi JY, Cho JS, Woo JH, Choi WS, Yang HJ, Hyun SY. Combination of S100B and procalcitonin improves prognostic performance compared to either alone in patients with cardiac arrest: A prospective observational study. Medicine (Baltimore). 2019 Feb;98(6):e14496. doi: 10.1097/MD.0000000000014496. — View Citation
Linssen J, Aderhold S, Nierhaus A, Frings D, Kaltschmidt C, Zanker K. Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B Clin Cytom. 2008 Sep;74(5):295-309. doi: 10.1002/cyto.b.20422. — View Citation
Pelinka LE, Petto H, Kroepfl A, Schmidhammer R, Redl HJEJoT. Serum Procalcitonin and S100B Are Associated with Mortality after Traumatic Brain Injury. European Journal of Trauma 2003; 29(5): 316-323.
Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9. — View Citation
Scaravilli V, Tinchero G, Citerio G; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Fever management in SAH. Neurocrit Care. 2011 Sep;15(2):287-94. doi: 10.1007/s12028-011-9588-6. — View Citation
Sevenet PO, Depasse F. Clot waveform analysis: Where do we stand in 2017? Int J Lab Hematol. 2017 Dec;39(6):561-568. doi: 10.1111/ijlh.12724. Epub 2017 Sep 6. — View Citation
Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288. Erratum In: JAMA. 2016 May 24-31;315(20):2237. — View Citation
Toh CH, Ticknor LO, Downey C, Giles AR, Paton RC, Wenstone R. Early identification of sepsis and mortality risks through simple, rapid clot-waveform analysis. Implications of lipoprotein-complexed C reactive protein formation. Intensive Care Med. 2003 Jan;29(1):55-61. doi: 10.1007/s00134-002-1557-2. Epub 2002 Nov 22. — View Citation
Weimann K, Zimmermann M, Spies CD, Wernecke KD, Vicherek O, Nachtigall I, Tafelski S, Weimann A. Intensive Care Infection Score--A new approach to distinguish between infectious and noninfectious processes in intensive care and medicosurgical patients. J Int Med Res. 2015 Jun;43(3):435-51. doi: 10.1177/0300060514557711. Epub 2015 Apr 7. — View Citation
Zakariah AN, Cozzi SM, Van Nuffelen M, Clausi CM, Pradier O, Vincent JL. Combination of biphasic transmittance waveform with blood procalcitonin levels for diagnosis of sepsis in acutely ill patients. Crit Care Med. 2008 May;36(5):1507-12. doi: 10.1097/CCM.0b013e3181709f19. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To validate the use of APTT CWA and ICIS, as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages. | Activated Partial Thromboplastin Time (APTT) clot waveform analysis (CWA) by flow cytometry-based method | SICU stay from day 1 to day 5 through to 2 years of blood test completion | |
Secondary | To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC activation markers over the time in relation to diagnosis of sepsis, development of positive blood cultures and mortality or recovery. | Blood parameter measurements using a 3-part and 5-part differential analyser will be performed. | SICU stay from day 1 to day 5 through to 2 years of blood test completion |
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