DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study)

NCT04624945 | Unknown DMC

• 1 other identifier: 2020/00020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sepsis; Hemorrhage Brain

Keywords

Severe sepsis in patients with neurological haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  SICU stay from day 1 to day 5 through to 2 years of blood test completion

Study Arms (1)

SICU cohort

150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to SICU of National University Hospital, Singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled. Frequency of blood sampling will be stipulated atday 1/2/3/4/5 to draw clinical relevance. An additional 0.5 tablespoonful (7.7ml) of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples.

Diagnostic Test: APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)

Interventions

APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin) DIAGNOSTIC_TEST

Primary Aim: To validate the use of APTT CWA (Activated partial thromboplastin time clot waveform analysis) and ICIS (Intensive Care Infection Score), as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages. Secondary Aim: To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC (white blood cell count) 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. KL-6, SP-A, MIG, presepsin are serum biomarkers - MIG (Monokine induced by gamma interferon), SP-A (Surfactant protein A), KL-6 (Krebs von den Lungen 6).

SICU cohort

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study. 150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to SICU of National University Hospital, Singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled.

You may qualify if:

• Adults 21 years and above
• Clinical/radiological suspicion or confirmation of neurological haemorrhage

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Sysmex Asia Pacific: collaborator

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

RECRUITING

Related Publications (11)

• 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.

  PMID: 21755388 BACKGROUND

• Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9.

  PMID: 20144219 BACKGROUND

• 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.

  PMID: 30732223 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26903335 BACKGROUND

• 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.

  PMID: 16607236 BACKGROUND

• 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.

  PMID: 28876509 BACKGROUND

• 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.

  PMID: 18434897 BACKGROUND

• 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.

  PMID: 12528023 BACKGROUND

• 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.

  PMID: 18431775 BACKGROUND

• 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.

  PMID: 25850686 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Sepsis; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage

Study Officials

• Will NH Loh, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Will NH Loh, MBBS

CONTACT

6772 4208; Will.Loh@nus.edu.sg

Christina YC Yip, PhD

CONTACT

67724109; christina_yip@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: November 25, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-06

Locations

SG (1)