The Nepean ICU Research Team provides 24/7 on-call support. If you have any questions or concerns, please don't hesitate to contact us after hours on: 0410 032 710
On this page is a list of all the trials we are currently running in Nepean ICU. Each study has information about recruitment as well as extra resources available. Trials are listed in alphabetical order.
P2X
Title of Project: The mechanisms leading to loss of function or gain of function of the human p2X4, P2X7, or P2Y Receptors and their biological roles in autoimmune, neutropathic, infectious, bone density and lymphoproliferative diseases.
Non-ventilated patients will be approached to sign a consent form to have a sample of blood taken and stored for analysis to study the inflammatory response.
Take home message: Research team will identify eligible patients, bedside staff may be asked to take blood specimens.
Non-ventilated patients will be approached to sign a consent form to have a sample of blood taken and stored for analysis to study the inflammatory response.
Take home message: Research team will identify eligible patients, bedside staff may be asked to take blood specimens.
PLUS
PLUS: A multi-centre, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) compared with 0.9% sodium chloride (saline) decreases 90-day mortality in critically ill patients requiring fluid resuscitation
Take home message: Please consider PLUS study for all patients requiring fluid resuscitation. All maintenance and bolus fluid will be PLUS study fluid for patients who are enrolled.
Take home message: Please consider PLUS study for all patients requiring fluid resuscitation. All maintenance and bolus fluid will be PLUS study fluid for patients who are enrolled.
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SAHaRA
Aneurysmal Subarachnoid Haemorrhage- Red Blood Cell Transfusion and Outcome _SAHaRA): A Randomised Controlled Trial
Principle Investigator: Professor Ian Seppelt
Primary Objective: To determine if a liberal compared to restrictive RBC transfusion strategy (Hb trigger ≤100g/L vs ≤80g/L respectively) in adult patients suffering from acute aSAH and anemia (Hb≤100g/L) decreases the combined rate of death and severe disability at 12 months.
Take home message: Get ready to recruit into this trial in March 2020
Principle Investigator: Professor Ian Seppelt
Primary Objective: To determine if a liberal compared to restrictive RBC transfusion strategy (Hb trigger ≤100g/L vs ≤80g/L respectively) in adult patients suffering from acute aSAH and anemia (Hb≤100g/L) decreases the combined rate of death and severe disability at 12 months.
Take home message: Get ready to recruit into this trial in March 2020
| SAHaRA Protocol.pdf |
SIMS
The SIMS study is an Internal Investigator led project run by Nepean ICU Investigators Dr Nalos and Dr Tang.
Sepsis and septic shock are associated with immune dysfunction predisposing patients to further infections, poor wound healing and increased morbidity and mortality. The immune dysfunction is characterized by lymphocyte apoptosis, anergy, relative increase in T regulatory cells, myeloid derived suppressor cells and deficiencies in MHC class II mediated antigen presentation.
This leads to impaired antigen recognition, reduced antimicrobial effector functions and poor microbial killing. In this study we will explore the ex vivo effects of IFNg and IMP321 treatment in lymphocyte cultures, specifically assessing the ability to correct the immune system dysfunction. We will employ multi-channel Flow cytometry and Nano-string technologies to characterize immune dysfunction by lymphocyte phenotyping and leukocyte gene expression, respectively. We will explore the ability of ex vivo IFNg and IMP321 to reprogram immune cells from a dysfunctional to a functional phenotype.
Take home message: Research team will identify eligible patients, bedside staff may be asked to take blood specimens.
Sepsis and septic shock are associated with immune dysfunction predisposing patients to further infections, poor wound healing and increased morbidity and mortality. The immune dysfunction is characterized by lymphocyte apoptosis, anergy, relative increase in T regulatory cells, myeloid derived suppressor cells and deficiencies in MHC class II mediated antigen presentation.
This leads to impaired antigen recognition, reduced antimicrobial effector functions and poor microbial killing. In this study we will explore the ex vivo effects of IFNg and IMP321 treatment in lymphocyte cultures, specifically assessing the ability to correct the immune system dysfunction. We will employ multi-channel Flow cytometry and Nano-string technologies to characterize immune dysfunction by lymphocyte phenotyping and leukocyte gene expression, respectively. We will explore the ability of ex vivo IFNg and IMP321 to reprogram immune cells from a dysfunctional to a functional phenotype.
Take home message: Research team will identify eligible patients, bedside staff may be asked to take blood specimens.
SPRINT SARI
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Is a global observation study on severe acute respiratory infection. All patients admitted to the ICU with an acute respiratory infection will be enrolled in the study by ICU research staff. This study has no intervention/no specimen collection/no bedside medical or nursing staff data collection or documentation. An opt–out model of consent has been approved for this study by the Alfred Ethics Committee. A patient brochure is displayed in the ICU waiting room.
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SUDDICU
SuDDICU: A randomised trial comparing the effect of using selective decontamination of the digestive tract (SDD) plus standard care, to standard care alone on hospital mortality in patients receiving mechanical ventilation in the intensive care unit (ICU).
General ICUs that admit mechanically ventilated patients will be randomised in the first 12-month period to either implement the SDD protocol in addition to standard care or to continue standard care without SDD, and then to cross over to the other arm during the second 12-month period
Thank you to all staff involved in the intervention phase of the SUDDICU trial. We now move into the control and ecology phases which do not require administration of SDD.
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Substudy - eSuDDICU
Sub study of SuDDICU looking at differences in microbial colonisation of the gastrointestinal tract and lungs before and after Selective decontamination of the digestive tract (SDD).
A convenient sample of patients recruited into SuDDICU, in whom it is possible to obtain at least two usable microbiological specimens (tracheal and perianal/rectal swabs, and faecal specimens) collected on day 1 (as soon as possible after recruitment into SuDDICU) and then as possible on days 3, 5, 7 and weekly thereafter until endotracheal extubation / cessation of ventilation via tracheostomy.
The following specimens will be collected:
A convenient sample of patients recruited into SuDDICU, in whom it is possible to obtain at least two usable microbiological specimens (tracheal and perianal/rectal swabs, and faecal specimens) collected on day 1 (as soon as possible after recruitment into SuDDICU) and then as possible on days 3, 5, 7 and weekly thereafter until endotracheal extubation / cessation of ventilation via tracheostomy.
The following specimens will be collected:
- A perianal or rectal swab (with visible faecal material)
- An endotracheal aspirate swab
- Faecal specimen
| specimen_collection_manual_of_operations_v1___3_.pdf |
TAME
This trial will determine whether increasing carbon dioxide to above normal levels [so-called targeted therapeutic mild hypercapnia (TTMH)] during the first 24 hours on a breathing machine in the intensive care unit improves brain recovery at 6 months compared to current standard care.
Supported by strong preliminary studies, significant improvements in patient outcomes are achievable with this simple and cost free therapy. Recruiting 1,700 patients, for multiple sites in many countries, this will be the largest trial ever conducted involving cardiac arrest patients admitted to the ICU.
If the TAME Cardiac Arrest Trial confirms that TTMH is effective, its findings will improve the lives of many and transform clinical practice.
Now actively recruiting patients. Please contact the ICU research team 24/7 in an OOHCA patient is admitted to the ICU
Supported by strong preliminary studies, significant improvements in patient outcomes are achievable with this simple and cost free therapy. Recruiting 1,700 patients, for multiple sites in many countries, this will be the largest trial ever conducted involving cardiac arrest patients admitted to the ICU.
If the TAME Cardiac Arrest Trial confirms that TTMH is effective, its findings will improve the lives of many and transform clinical practice.
Now actively recruiting patients. Please contact the ICU research team 24/7 in an OOHCA patient is admitted to the ICU
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REMAP CAP
Randomised, Embedded, Multifactorial, Adaptive, Platform trial for Community-Acquired Pneumonia.
All patients admitted to the Nepean ICU with an admitting diagnosis of Community Acquired Pneumonia should be screened for eligibility for enrolment into the REMAP CAP trial. Antibiotic treatment will then be directed through the study protocol.
Take home message: MEDICAL STAFF: Does your patient have an admitting diagnosis of Community Acquired Pneumonia?
YES- go to remapcap.spinnakersoftware.com to begin the enrolment process.
Checking trial eligibility of patients admitted with Community Acquired Pneumonia needs to be an essential part of the unit admission process for all CAP admissions for the next 4 years.
All patients admitted to the Nepean ICU with an admitting diagnosis of Community Acquired Pneumonia should be screened for eligibility for enrolment into the REMAP CAP trial. Antibiotic treatment will then be directed through the study protocol.
Take home message: MEDICAL STAFF: Does your patient have an admitting diagnosis of Community Acquired Pneumonia?
YES- go to remapcap.spinnakersoftware.com to begin the enrolment process.
Checking trial eligibility of patients admitted with Community Acquired Pneumonia needs to be an essential part of the unit admission process for all CAP admissions for the next 4 years.
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| remap-cap_-_pandemic_appendix_to_core_-_v1.0_20200131.pdf |