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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.
ICU-ROX trips
The Intensive Care Unit Randomised Trial Comparing Two Approaches to Oxygen Therapy: Translation of Research into Practice.
Part of a programme of research assessing whether participating in the ICU-ROX trial (liberal vs conservative approach to oxygen therapy in mechanically ventilated ICU patients) changes attitudes and practices in regards to oxygen therapy. Comparing the practices of ICUs that participated against those that did not participate in the ICU-ROX trial.
The ICU_ROX TRIPS study programme is comprised of three separate studies:
1. An inception cohort study
2. Practitioner attitudes survey
3. Retrospective cohort study of oxygen management over time
The inception cohort study and practitioner attitudes survey will be conducted three times; before the ICU-ROX study starts, after it has finished (but before the results are published) and 6-12 months after the results are published.
The retrospective cohort study will use an existing Australian & New Zealand (ANZ) ICU database Australian & New Zealand Intensive Care Society (ANZICS) Centre for Outcome & Resource Evaluation (CORE) and study oxygen use over time.
Part of a programme of research assessing whether participating in the ICU-ROX trial (liberal vs conservative approach to oxygen therapy in mechanically ventilated ICU patients) changes attitudes and practices in regards to oxygen therapy. Comparing the practices of ICUs that participated against those that did not participate in the ICU-ROX trial.
The ICU_ROX TRIPS study programme is comprised of three separate studies:
1. An inception cohort study
2. Practitioner attitudes survey
3. Retrospective cohort study of oxygen management over time
The inception cohort study and practitioner attitudes survey will be conducted three times; before the ICU-ROX study starts, after it has finished (but before the results are published) and 6-12 months after the results are published.
The retrospective cohort study will use an existing Australian & New Zealand (ANZ) ICU database Australian & New Zealand Intensive Care Society (ANZICS) Centre for Outcome & Resource Evaluation (CORE) and study oxygen use over time.
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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POINT PREVALENCE PROGRAM
The Point Prevalence Program is a unique collaborative program of coordinated observational research across Australian and New Zealand adult and paediatric intensive care units, and was established in 2009 by the ANZICS Clinical Trials Group in partnership with The George Institute.
The program aims to facilitate research characterising ICU patient populations and aspects of current clinical practice and management. It also provides researchers with the opportunity to collect pilot data to support future studies and applications for funding.
The Point Prevalence Program consists of specific single-day point prevalence studies conducted on designated days each year in Australian and New Zealand adult and paediatric ICUs.
Each study day involves the collection of standardised, generic observational data, accompanied by specific observational data as requested by individual researchers using the program.
The use of standardised study tools to address multiple study questions within a single structured program minimises the burden on sites and considerably reduces demands on researchers conducting observational studies.
Currently there are no planned dates for the next Point Prevalence Program data collection.
The program aims to facilitate research characterising ICU patient populations and aspects of current clinical practice and management. It also provides researchers with the opportunity to collect pilot data to support future studies and applications for funding.
The Point Prevalence Program consists of specific single-day point prevalence studies conducted on designated days each year in Australian and New Zealand adult and paediatric ICUs.
Each study day involves the collection of standardised, generic observational data, accompanied by specific observational data as requested by individual researchers using the program.
The use of standardised study tools to address multiple study questions within a single structured program minimises the burden on sites and considerably reduces demands on researchers conducting observational studies.
Currently there are no planned dates for the next Point Prevalence Program data collection.
| Point Prevalence Program Protocol.pdf |
REVISE
REVISE- Re-Evaluating the inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis in ICU
This is a planned 4,800 patient randomised control trial (RCT) designed to answer 2 key clinical questions.
1. Placebo non-inferior for GI bleeding
2. Placebo superior at reducing harm.
Inclusion criteria: MV and continue the day after tomorrow, either intervention (placebo) or control (PPI) is equally appropriate.
Exclusion criteria: Age < 18, MV for ≥ 72 h, PPI indicated for recently identified important indication, dual anti‐platelet therapy, palliative care, received > one day equivalent of PPI in ICU.
This study will commence in 2019.
This is a planned 4,800 patient randomised control trial (RCT) designed to answer 2 key clinical questions.
1. Placebo non-inferior for GI bleeding
2. Placebo superior at reducing harm.
Inclusion criteria: MV and continue the day after tomorrow, either intervention (placebo) or control (PPI) is equally appropriate.
Exclusion criteria: Age < 18, MV for ≥ 72 h, PPI indicated for recently identified important indication, dual anti‐platelet therapy, palliative care, received > one day equivalent of PPI in ICU.
This study will commence in 2019.
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.
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STARRT-AKI
STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial
The aim of this study is to determine whether immediate initiation of renal replacement therapy (RRT), compared to delayed approach to RRT initiation, improves survival and renal recovery (RRT independence) at 90 days in critically ill patients with severe AKI. The research team perform all study related roles for this trial. ICU patients with acute kidney injury will be screened for eligibility and randomised by research staff. You may be asked to commence dialysis within a certain timeframe to comply with the study protocol. All decisions to enrol are done so with the support of the ICU consultant. No bedside data collection or study specific assessment is required by the bedside nurse.
Study start 2015. Study completion 2019.
Please approach Staff Specialist Dr Louise Cole (Principal Investigator) with any queries related to this study.
The aim of this study is to determine whether immediate initiation of renal replacement therapy (RRT), compared to delayed approach to RRT initiation, improves survival and renal recovery (RRT independence) at 90 days in critically ill patients with severe AKI. The research team perform all study related roles for this trial. ICU patients with acute kidney injury will be screened for eligibility and randomised by research staff. You may be asked to commence dialysis within a certain timeframe to comply with the study protocol. All decisions to enrol are done so with the support of the ICU consultant. No bedside data collection or study specific assessment is required by the bedside nurse.
Study start 2015. Study completion 2019.
Please approach Staff Specialist Dr Louise Cole (Principal Investigator) with any queries related to this study.
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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
Intervention period commenced 9th April 2018
Please chart selective decontamination of the digestive tract (SDD) for all eligible ventilated patients.
SDD oral paste, SDD gastric suspension and 4 day course IV antibiotic as per protocol.
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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.
Soon to commence recruitment.
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.
Soon to commence recruitment.
| TAME Synopsis.pdf |
TTM2
The TTM2 trial is a continuation of the collaboration that resulted in the previous Targeted Temperature Management after out-of-hospital cardiac arrest trial (TTM1). It is anticipated to supersede the TTM1 trial as the largest trial on temperature management as a post-cardiac arrest treatment.
The TTM1 trial compared two strict target temperature regimens of 33°C and 36°C in adult patients, who have sustained return of spontaneous circulation and are unconscious after out-of-hospital cardiac arrest, when admitted to hospital. The trial found that cooling to 33°C after witnessed cardiac arrest conferred no benefits compared with 36°C, this has led to much debate in the hypothermia community.
TTM2 an international, multicenter, randomised control trial in which a target temperature of 33°C after cardiac arrest will be compared to normothermia and early treatment of fever.
Soon to commence recruitment.
The TTM1 trial compared two strict target temperature regimens of 33°C and 36°C in adult patients, who have sustained return of spontaneous circulation and are unconscious after out-of-hospital cardiac arrest, when admitted to hospital. The trial found that cooling to 33°C after witnessed cardiac arrest conferred no benefits compared with 36°C, this has led to much debate in the hypothermia community.
TTM2 an international, multicenter, randomised control trial in which a target temperature of 33°C after cardiac arrest will be compared to normothermia and early treatment of fever.
Soon to commence recruitment.
| Protocol.pdf |