DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study) (DISSIPATE)
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| ClinicalTrials.gov Identifier: NCT04624945 |
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Recruitment Status :
Recruiting
First Posted : November 12, 2020
Last Update Posted : January 6, 2022
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Sponsor:
National University Hospital, Singapore
Collaborator:
Sysmex Asia Pacific Pte Ltd
Information provided by (Responsible Party):
National University Hospital, Singapore
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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).
| Condition or disease | Intervention/treatment |
|---|---|
| Sepsis Hemorrhage Brain | Diagnostic Test: APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin) |
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. No adverse events are expected as a result of this study as patients do not deviate from the current standard of care. Frequency of blood sampling will be stipulated at day 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. In total, an additional volume of 2.5 tablespoonful (38.5ml) of blood will be collected from each subject over a period of 5 days. Residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests. All ICU patients will have arterial lines inserted as part of routine care, so there will not be pain from the blood sampling. In the current study, measurements will be made on the routine laboratory haematology, coagulation and immunoassay analyzers. Research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis. In addition, the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study.
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study) |
| Actual Study Start Date : | November 25, 2020 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Diagnostic Test: APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)
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). |
Primary Outcome Measures :
- 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. [ Time Frame: SICU stay from day 1 to day 5 through to 2 years of blood test completion ]Activated Partial Thromboplastin Time (APTT) clot waveform analysis (CWA) by flow cytometry-based method
Secondary Outcome Measures :
- 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. [ Time Frame: SICU stay from day 1 to day 5 through to 2 years of blood test completion ]Blood parameter measurements using a 3-part and 5-part differential analyser will be performed.
Biospecimen Retention: Samples Without DNA
Serum samples
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624945
Contacts
| Contact: Will NH Loh, MBBS | 6772 4208 | Will.Loh@nus.edu.sg | |
| Contact: Christina YC Yip, PhD | 67724109 | christina_yip@nuhs.edu.sg |
Locations
| Singapore | |
| National University Hospital, Singapore | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Will NH Loh, MBBS 6772 4208 Will.Loh@nus.edu.sg | |
| Contact: Christina YC Yip, PhD 67724109 christina_yip@nuhs.edu.sg | |
| Principal Investigator: Will NH Loh, MBBS | |
| Sub-Investigator: Christina YC Yip, PhD | |
| Sub-Investigator: Eng Soon Yap, MBBS | |
| Sub-Investigator: Shir Ying Lee, MBBS | |
| Sub-Investigator: Jiayi Shen, MBBS | |
Sponsors and Collaborators
National University Hospital, Singapore
Sysmex Asia Pacific Pte Ltd
Investigators
| Principal Investigator: | Will NH Loh, MBBS | National University Hospital, Singapore |
Study Documents (Full-Text)
Publications:
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.
| Responsible Party: | National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT04624945 |
| Other Study ID Numbers: |
2020/00020 |
| First Posted: | November 12, 2020 Key Record Dates |
| Last Update Posted: | January 6, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by National University Hospital, Singapore:
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Severe sepsis in patients with neurological haemorrhage |
Additional relevant MeSH terms:
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Sepsis Toxemia Hemorrhage Infections Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Thromboplastin Hemostatics Coagulants |