Research Critical Care STH

There are currently no drug treatments that have been shown to be effective in the treatment of Covid 19. The national agenda is therefore to recruit all Covid 19 patients into a research trial as some drugs may be effective in treatment. 

The Recovery trial and Remap Cap trial are adaptive platform studies, which means that treatments given are continuously evaluated  for effectiveness, so some treatments may be noted as effective during recruitment and therefore drug treatment of Covid 19 may be recommended during the trial. Whilst there are many studies in the pipeline, these are being prioritised by CMO and currently only 4 top priority. In critical care in JCUH we are actively recruiting to 3 studies, although we may also have patients from the ward based Recovery trial coming to critical care on interventional treatment. Which arms we choose will depend on many factors, including national shortages of drugs such as B Interferon.

The 3 CRITICAL CARE studies are:

      • CP-UK ISARIC (PI David Chadwick forward patients & Steve Bonner critical care patients). This is observational, needing 3 purple top blood bottles, 1 gold top, 1 blue RNA sample when bottles are available, 1 nasal swab, 1 oral swab and a urine specimen  at recruitment to characterise the virus and outcomes. All patients are suitable. PI: David Chadwick for the ward patients and Steve Bonner for critical care patients. 
      • Genomicc. (PI Steve Bonner)Observational sampling study, requiring 2 purple top bottles, investigating genetic linkage to outcome from sepsis, now with Covid 19 arm. Aim is to target treatment to specific genotypes. 
      • Remap Cap  (PI Jeremy Henning).  Adaptive Platform RCT investigating outcomes in CAP.  We are already in the antibiotics in Pneumonia arm and now with a Covid 19 arm comparing Steroids vs Hydroxychloroquine vs Toculuczimab vs Kalitra vs B Interferon. We have not yet signed up to the complex drugs, but this coming and we will update. PI is Jeremy Henning. So currently the arms we are doing:

                1. Antibiotics – co-amoxyclav vs tazocin plus Clarithromycin for CAP. 
                2. Macrolides – IV Clarithromycin for 3 days vs 10 days for anti-inflammatory effect as well as antibiosis
                3. Steroids – either none, 5 days or 10 days. 

We will also see patients who have already been recruited from the Recovery Trial ( PI David Chadwick)

There are further level 1 priority studies in the trust which should not involve critical care, e.g.  Priest is looking at triage in ED and UKOSS  is investigating Pandemic COVID-19 in Pregnancy. 

It is imperative that we support these studies. We currently have no treatment for Covid19 and the UK is in an almost unique position with a national infrastructure to rapidly respond and find treatments that work.  It is possible that treatments may emerge during the trials and be recommended. 

We may ask Critical Care consultants to give professional consultee consent if relatives cannot be contacted and the patient is unconscious. Retrospective consent will be undertaken by the research team. Patients may potentially be in 3 or 4 studies. Our research nurse is trying to minimise nursing workload by asking for samples only at a time when the nurses are already taking samples, e.g. in the morning blood run. He has created premade packs and will package these for the path lab himself together with a simple document outlining which samples are required.

Thank you all,

Prof. Stephen Bonner

CURRENT STUDIES



Protocol



A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients



HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial Protocol


BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis: the ADAPT-Sepsis Trial

ADAPT-sepsis trial summary

ADAPT-sepsis trial protocol






Antifungal stewardship opportunities with rapid tests for fungal infection in critically ill patients. The purpose of this project is to assess the performance of three rapid tests for fungal infection. The accuracy of these tests will be compared and the optimal test (or combination) identified. The emphasis will be on their ability to rule-out infection.   

Study protocol and presentation


SoS

Suspiction of Sepsis -  Validation Study

A multi-centre validation of the ability of Suspicion Of Sepsis (SOS) diagnosis codes to identify bacterial infections diagnosed during hospital inpatient spells: a review of medical records. 

Protocol





Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis

 

 

FUTURE STUDIES 



The OPTIC-ICP study: Optic Nerve Sheath Ultrasound to track changes in Intra Cranial Pressure.

Protocol


Genetics of Susceptibility and Mortality in Critical Care

Protocol



 Epidemiology and determinants of outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care. A multinational cohort study by the ESICM Trials Group. 

Protocol




 Treatment of invasively ventilated adults with Early Activity and Mobilisation (TEAM) trial.

Protocol



PREVIOUS STUDIES


 

Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension 



 A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors vs. histamine-2 receptor blockers for ulcer prophylaxis therapy in the Intensive Care Unit 

Protocol



 WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE (WEAN SAFE STUDY) 

Study protocol 

Critical Care Research Group Meetings Dates

The Critical Care Services at South Tees NHS Hospitals is very actively involved with research. We are very keen that all colleagues are involved and participate in the ongoing research and future research projects.

The research lead for The James Cook University Hospital and Friarage Hospital Critical Care Units is Prof Stephen Bonner.

The critical care research nurse  is Keith Hugill.


Do not hesitate to contact him if you need any information of advice on tel. 01642 854271 or ext. 54271 or bleep through main switchboard.



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