Definitions for Data Collection

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AIDA WP1 researcher package

Definitions for data collection

SOFA blood pressure 1

SOFA Glasgow coma scale 1

Immunosuppressive drugs 2

RIFLE Criteria 3

Adverse events 3

Temperature 3

Calculation of respiratory SOFA component 4

Charlson comorbidity index definitions 5

Steroid Conversion Table 5

Definitions for nosocomial infections (adapted from CDC definitions) for outcome assessment 6

Trial flow form 8

SOFA blood pressure

Vasopressor drug doses are in mcg/kg/min

SOFA Glasgow coma scale

For mechanically ventilated, anesthesized patients, we will score the patient on the last available consciousness level known before intubation or when last sedation was discontinued

Immunosuppressive drugs

This is a non-exhaustive list – other drugs may be relevant.

Glucocorticoids (by equivalent dose)

Antimetabolites (6-mercaptopurine, azathioprine, methotrexate)

Alkylating agents (cyclophosphamide, cisplatin)

Anthracyclines

Calcineurin inhibitors - tacrolimus, sirolimus, cyclosporine

Mycophenolate mophetil

Anti-TNF agents and antibodies (rituximab, etanercept ,infliximab)

RIFLE Criteria

Category / GFR Criteria / Urine Output (UO) Criteria
Risk / Increased creatinine x1.5 or GFR decrease > 25% / UO < 0.5ml/kg/h x 6 hr
Injury / Increased creatinine x2 or GFR decrease > 50% / UO < 0.5ml/kg/h x 12 hr
Failure / Increase creatinine x3 or GFR decrease > 75% / UO < 0.3ml/kg/h x 24 hr or Anuria x 12 hrs
Loss / Persistent ARF = complete loss of kidney function > 4 weeks
ESKD / End Stage Kidney Disease (> 3 months)

GFR; Glomerular Filtration Rate

ARF; Acute Renal Failure

UO; Urinary Output

ESKD; End Stage Kidney Disease

Adverse events

Diarrhea – passage of 3 or more preformed stools over 24 hours

Clostridium difficile associated disease – clinical signs + positive toxin essay

Temperature

Preferably document rectal – of oral, add 0.4C

Calculation of respiratory SOFA component

SOFA = PaO2/FiO2

FiO2 =

0.2 – Room air

0.3 – Nasal cannula

0.4 – Oxygen mask

1 – Non-rebreather oxygen mask with reservoir bag

Mechanical ventilation – by ventilator settings

When PaO2 in unknown, it can be estimated from % saturation values:

Uniform rules of thumb:

Saturation / PaO2 (mmHg) / SOFA for room air (0.2) / SOFA for oxygen via nasal cannula (FiO2 0.3)
80% / 60 / 1 / 2
85% / 70 / 1 / 2
90% / 90 / 0 / 1
95% / 100 / 0 / 1
100% / 100-140 / 0 / 0-1

Charlson comorbidity index definitions

·  Chronic pulmonary disease - symptomatic dyspnea due to chronic respiratory

conditions (including asthma)

·  Connective tissue disease – Systemic Lupus Erythematosus, polymyositis, mixed connective tissue disease, polymyalgia rheumatica, moderate to severe rheumatoid arthritis

·  Ulcer disease - Patients who have required treatment for peptic ulcer disease

·  Mild liver disease - cirrhosis without portal hypertension, chronic hepatitis

·  Diabetes with end organ damage - retinopathy, neuropathy, nephropathy

·  Moderate or severe renal disease - creatinine >3mg% (265 umol/l), dialysis,

transplantation, uremic syndrome

·  Solid tumor (non metastatic) - exclude non-melanomatous skin cancers and in- situ cervical carcinoma

·  Leukemia- Chronic/acute myelogenous leukemia, chronic/acute lymphocytic leukemia, polycythemia vera (AML,CML, CLL, ALL, PV)

·  Lymphoma - Multiple myeloma, non Hodgkin's lymphoma, Hodgkin's, Waldenström's

·  Moderate or severe liver disease - cirrhosis with Pulmonary hypertension +/- variceal bleeding

Steroid Conversion Table

Glucocorticoid / Equivalent dose
Cortisone / 25
Hydrocortisone / 20
Methylprednisolone / 4
Prednisolone / 5
Prednisone / 5
Triamcinolone / 4
Betamethasone / 0.6-0.75
Dexamethasone / 0.75

Definitions for nosocomial infections (adapted from CDC definitions) for outcome assessment

See also: http:// www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf

Pneumonia

Patient has a chest radiographic examination that shows new or progressive infiltrate, consolidation, cavitation, or pleural effusion with new onset of purulent sputum or change in character of sputum and microbiological documentation:

·  Organisms cultured from blood OR

·  Isolation of an etiologic agent from a sputum specimen or deep suction specimen

VAP

Nosocomial pneumonia in a patient on mechanical ventilatory support (by endotracheal tube or tracheostomy) for >48 hours

Catheter-associated BSI

All BSIs that occur in patients with CVCs, when other sites of infection have been excluded

Catheter-related BSI

Bacteremia in a patient with an intravascular catheter with at least one positive blood culture obtained from a peripheral vein, clinical manifestations of infections (i.e., fever, chills, and/or hypotension), and no apparent source for the BSI except the catheter.

One of the following should be present:

·  a positive semiquantitative (>15 CFU/catheter segment) or quantitative (>103 CFU/catheter segment catheter) culture whereby the same organism (species and antibiogram) is isolated from the catheter segment and peripheral blood

·  simultaneous quantitative blood cultures with a >5:1 ratio CVC versus peripheral

·  differential period of CVC culture versus peripheral blood culture positivity of >2 hours

Meningitis or ventriculitis

Criterion 1: Patient has organisms cultured from cerebrospinal fluid (CSF).

Criterion 2: Patient has at least one of the following signs of symptoms with no other recognized cause: fever (.38° C), headache, stiff neck, meningeal signs, cranial nerve signs, or irritability

and at least one of the following:

·  Increased white cells, elevated protein and/or decreased glucose in CSF

·  Organisms seen on Gram stain of CSF

·  Organisms cultured from blood

Urinary tract infection

Patient has at least one of the following signs or symptoms with no other recognized cause: fever (.38° C), urgency, frequency, dysuria, or suprapubic tenderness

and patient has one of the following:

·  Positive urine culture, that is >105 microorganisms per cm3

·  Urine culture with no more than two species of microorganisms.

Primary bacteremia

Patient has a recognized pathogen cultured from one or more blood cultures and organism cultured from blood is not related to an infection at another site.

Deep/ organ space surgical site infection

Infection of the deep fascia, organ, bone, joint space or prosthetic device presenting within 30 days of surgery, or within 1 year in the case of a prosthetic device implementation

and patient has

One or more pathogens isolated from pus or a normally sterile site

Severe soft-tissue and bone infections

Deep soft tissue infections or osteomyelitis

and patient has at least one of the following:

·  Pathogen/s isolated from a surgical specimen

·  Pathogen/s isolated from a biopsy

·  Pathogens isolated from a normally sterile site

Trial flow form

Last 5 digits of Epi-info UID: ______

Randomization number: ______

ð  Notification from laboratory for isolation of CR-GNB.

ð  Application of inclusion criteria: relevant pathogen (as defined above) and relevant clinical syndrome (BSI, VAP, HAP, probable VAP or UTI) define a potentially eligible patient

ð  For all potentially eligible patients, enter patient into Epi-Info (first and second page). Follow trial flow according to inclusion/ exclusion criteria – patient not fit for study, observational study or RCT. Complete EpiInfo for all patients classified for the observational study or RCT.

For RCT only:

ð  Document last 5 digits of Epi-info unique identifier above.

ð  Perform randomization at: http://ozeuss.pythonanywhere.com

(username:, password: aidaadmin)

ð  Document randomization number given above and enter to EpiInfo.

ð  Take clinical cultures as appropriate + rectal surveillance sample. Ensure storing of index culture in the lab.

ð  Time 0 – colistin loading dose 9MIU in 30min, followed by meropenem 2gr in 3hrs. Document start/ stop timing

ð  45min – colistin level testing, take on ice to centrifugation with 15 min of sampling, centrifuge using cold centrifuge and freeze (-70˚C). Document timing of sample and centrifugation.

ð  Make sure that the 8, 12 and 16 hr. doses are documented and implemented

ð  8hr – IV meropenem 2gr in 3 hrs

ð  12hr – colistin 4.5 MIU in 30 min

ð  16hr – IV meropenem 2gr in 3 hrs

ð  22hr – document start/ stop timing of the 2nd dose of colistin and 2nd/ 3rd doses of meropenem. Colistin level testing, carry on ice and centrifuge within 15 min and freeze immediately
(-70˚C). Instruct on continued treatment and repeat cultures as clinically appropriate.

ð  24hr - colistin 4.5 MIU (30min) followed by meropenem 2gr (3hr)

ð  48hr– clinical follow-up, adherence monitoring (avoid treatment modifications until 72 hrs), blood cultures if febrile

ð  Day 5 - clinical follow-up, clinical cultures as appropriate, blood cultures if febrile

ð  Day 7 – rectal surveillance sample, sputum culture for HAP/VAP, urine culture for UTI, blood cultures if febrile, outcome data collection

ð  Day 9 - clinical follow-up, clinical cultures as appropriate, blood cultures if febrile

ð  Day 10 – clinical follow-up, clinical cultures as appropriate, blood cultures if febrile

ð  Day 14 –rectal surveillance sample, clinical cultures as appropriate, blood cultures if febrile, outcome data collection

ð  21 days – rectal surveillance sample

ð  28 days –rectal surveillance sample, outcome data collection

If patient discharged at any time before day 28, complete case report form at the time of discharge, except for death. If death before day 28, complete case report form at the time of death. Complete as many fields as possible given known information.

Store/ freeze

ð  Index culture

ð  All positive follow-up clinical isolates from blood cultures or other samples

ð  Day 7 sputum/ urine cultures

ð  4 X rectal surveillance incubated in BHI

ð  2 X colistin/ meropenem level sampling