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0by25 AN ISN HUMAN RIGHTS INITIATIVE

Dear investigator, Welcome to the 0by25 initiative’s Global Snapshot! Acute Kidney Injury (AKI) is a major problem worldwide but, although this medical condition is frequent, its region-‐specific incidence and characteristics are still not well defined. Risk factors and etiologies for AKI may vary greatly from one area to another since climate, cultures, genetics and environmental factors differ between countries and continents. Diagnostic tools and resources available for dialytic and non-‐dialytic-‐treatments are not uniformly distributed across the world and their availability vary greatly depending on the socio-‐economic characteristics of each country. This Global Snapshot will help evaluate these differences in AKI across the world and draw a picture of the current severity of the situation. Once this is established, we will then be able to evaluate the tools needed to meet this initiative’s aim: eliminating preventable deaths from AKI by 2025. We aim to include 5,000-‐10,000 patients in this study. The accuracy and success of the Global Snapshot is dependent on your enthusiasm and participation. We acknowledge that your time is very precious with your busy schedule and greatly appreciate that you are making time for this very important global health issue. In this package, you will find useful information concerning the study’s design, protocol, tools and template for IRB approval. Any questions regarding the study may be addressed to: [email protected] [email protected] [email protected] For any problems with the website and data submission, please contact: [email protected] Thank you for your effort and support. Warm regards, Global Snapshot Team for the 0by25 initiative Ravindra L. Mehta , (Co-‐Chair Global Snapshot Team), San Diego, USA Norbert Lameire (Co-‐Chair Global Snapshot Team), Gent, Belgium Dwomoa Adu, Accra, Ghana Stuart Goldstein, Cincinnati, USA Adeera Levin, Vancouver, Canada Etienne Macedo, San Paolo, Brazil John Kellum, Pittsburg, USA Michael Joannidis, Innsbruck, Austria Nattachai Srisawat, Bangkok, Thailand Melanie Godin, San Diego, USA

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Content of Introductory Package Global Snapshot

Protocol summary 3 Detailed summary 4 Background and significance 4 Aims 5 Patient screening and case definition 6

Data collection 7 Human subjects/Ethics 8 Steering and advisory committees 9

References 10

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Global Snapshot: Protocol summary Design

§ Cross-‐sectional observational study

Aim of the study

§ Primary § Establish point incidence of acute kidney injury (AKI) in different settings

around the world § Secondary

§ Compare risk factors, etiologies, diagnosis, management and outcomes of AKI in different countries.

§ Determine resources available for recognition non dialytic and dialytic management and follow up of patients with AKI in different settings and countries

Patient population

§ Inclusion: AKI patients of all ages under your care on a chosen “Index day” (see definition of “Index day” later in text.

§ Exclusion: Patients receiving chronic dialysis (hemo or peritoneal dialysis), renal transplant recipients and prisoners.

Human subjects/Ethics

§ According to local regulation. Centers self certify human subjects approval § A template of IRB application is available as needed (See appendix)

Study duration

§ You will choose one (1) day of your convenience during the study period (September 29th 2014 to November 9th 2014) that will be called “Index day” were your will record available clinical and laboratory information on all AKI patients under your care on that day.

§ You will be asked to record outcome information on the patients seven (7) days later.

Data collection

§ For each patient, you will have to fill out one of each of the four (4) following Case Report Forms (CRF) each including between 8 and 18 questions on the web-‐based CRF available on the 0 by 25 website: 0by25.org

§ CRF 1: Screening patient information § CRF 2: Initial clinical data § CRF 3: Diagnostic and treatment information § CRF 4: Outcome information

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Global Snapshot: Detailed summary Background and significance Acute Kidney Injury (AKI) is a complex disorder with a multitude of possible etiologies and clinical manifestations. Patients may present with a wide spectrum of symptoms ranging from being asymptomatic to completely anuric. It is associated with high mortality and co-‐morbidities such as chronic kidney disease or dialysis dependency. Incidence of AKI varies greatly according to patient risk factors or localization of population being studied (i.e.: hospital, ICU or community). There is a lack of knowledge of the region-‐specific (individual country and continent) characteristics of AKI. Little is known about the incidence, etiologies, resources and barriers to treatments of this condition in many parts of the world. In 2013, the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations’ World Kidney Day was focused on AKI to with aims to raise awareness of this problem to eventually stimulate global discussion, education and policy development to prevent and treat AKI. The AKI Advisory Group for the American Society of Nephrology has published a meta-‐analysis evaluating world incidence of AKI. After including 154 studies (n=3,855,911) that met KDIGO definitions of AKI, they found the incidence of AKI to be as high as 21.6% in adults and 33.7% in children. The reported mortality rates were 23.9% in adults and 13.8% in children. This mortality rate was inversely related to country income and percentage of gross domestic product spent on total health expenditure. This study identified important gaps in worldwide AKI knowledge with very little or no data coming from regions where the expected incidence and mortality would be very high (Africa, South Asia, Southeastern Asia and Central Asia). 89% of the studies included in this meta-‐analysis came from countries in the Northern latitude (North America and Northern Europe). Another important point is that most of the data came from retrospective studies or post-‐hoc analysis.1 Although these initiatives mentioned above were very insightful and identified important gaps in knowledge, more effort is required to understand this problem affecting all regions of the globe. The 0 by 25 initiative is sponsored by the ISN aiming to “Elimination of preventable deaths from AKI by 2025”. In order to eventually implement resources and tools to help prevent, diagnose and treat this AKI, we must first have an accurate picture of region-‐specific incidence, risk factors, available resources and barriers to diagnosis and treatment. This “Global Snapshot” cross-‐sectional observational study is the first step in identifying the true burden of AKI worldwide. This project aims to collect data on AKI cases seen in a 24-‐hour period across the world. The study is open to individual physicians across the world who agree to participate by providing de-‐identified clinical and lab data of patients with AKI that they care for on a designated day of their choice.

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Aim of the study Primary

-‐ Establish point incidence of acute kidney injury (AKI) in different settings around the world

Secondary -‐ Compare risk factors, etiologies, diagnosis, management and outcomes of AKI in different countries. -‐ Determine resources available for recognition non dialytic and dialytic management and follow up of patients with AKI in different settings and countries

Study duration

§ You will choose at least one (1) day of your convenience during the study period (September 29th 2014 to November 9th 2014) that will be called “Index day”* where you will record available clinical and laboratory information on all AKI patients under your care on that day.

§ You will be asked to record outcome information on the enrolled patients seven (7) days later.

*Individual physicians can select more than one Index day to enroll patients into the study within the study period. The Index day can be changed if necessary.

Patients and case definition

§ Inclusion: Confirmed AKI from any etiology encountered within ±3 days of “Index day” identified for data capture

§ Exclusion: Patients receiving chronic dialysis (hemo or peritoneal dialysis), renal transplant recipients and prisoners.

§ What is “Confirmed AKI”?

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A patient has “Confirmed AKI” if they meet at least one of the modified KDIGO Criteria

a) Increase or decrease in serum creatinine >0.3 mg/dl from reference b) Increase or decrease in serum creatinine > 50% from reference c) Urine output <400 ml/day for adults or approximately < 0.5ml/kg/hr over 24 hrs

§ What is reference creatinine? Most recent serum creatinine available in the last 12 months before presenting event

§ What if the patient does not have a serum creatinine in last 12 months? Use the initial creatinine as reference and compare to a subsequent creatinine to establish the diagnosis of AKI

§ What if the patient does not meet the “Confirmed AKI” criteria by “Index day”?

He might still have “Suspected AKI” and later meet the criteria for the study. These patients should be tracked. If they meet “Confirmed AKI” criteria within 3 days after your chosen “Index day”, they should be included in the study.

§ What is “Suspected AKI”?

Oliguria (<200 mL/6 hours) and any AKI-‐related clinical signs or symptoms listed below or urinalysis/dipstick abnormality. *All suspected AKI cases must be confirmed prior to enrollment.

AKI-‐related clinical signs or symptoms: dehydration, diarrhea, vomiting,

increased thirst, excessive sweating, fever, any infection, hypotension, weakness, shortness of breath, loss of weight, jaundice, pallor, allergic reaction, swelling, trauma, poisoning, animal/insect bite, pregnancy or delivery related symptoms

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Data collection

§ We aim for a large participation in this study (5,000-‐10,000 patients) and therefore narrowed the required collection of information to as minimal as possible without compromising the completeness of the study. We would appreciate that you include all the patients meeting the inclusion criteria in this study.

§ You will have access to the online Case Report Forms (CRF) to enter patient information through the 0 by 25 website: 0x25.org

§ For each patient, you will have to fill out one of each of the four (4) following CRF

each including between 8 and 18 questions § CRF 1: Screening patient information § CRF 2: Initial clinical data § CRF 3: Diagnostic and treatment information § CRF 4: Outcome information

§ The data that we ask that you collect is de-‐identified information that you have

already available in the patient’s chart (see Table 1 below). When you do not have the information, you always have the option of entering that it is non-‐available (N/A).

§ Outcomes § Dialysis requirement § Renal recovery § Mortality § Follow up evaluation after AKI

Symptoms • Oliguria ( UO < 200 ml/6h) • AKI-‐related clinical signs or symptoms

Lab ConfirmaFon

• CreaFnine elevaFon or decrease of at least 0.3 mg/dl or 50% from prior value (no Fme limit) • Urinalysis • Imaging studies Ultrasound

Enrollment •  Meet criteria within ±3 days prior to Index day

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TABLE 11 Index day AKI confirmation day 7 days post AKI confirmation

Study ID number* X X X Age/Gender/Ethnicity X Weight and height X CKD status X Number of kidneys X Baseline creatinine X Signs and symptoms associated with AKI*

X

AKI diagnosis criteria met X Date and location of AKI diagnosis

X

Creatinine and BUN# at diagnosis

X

Urinalysis and output X Fluid balance status X Risk factors and co-‐morbidities

X

Suspected etiology X Tools for diagnosis X Treatment of AKI received X Mortality and cause X Hospital length of stay X Disposition post hospital discharge

X

Dialysis dependency status X Last available creatinine X Renal recovery status X Renal biopsy results (if applicable)

X

Planned follow up X Human subject/Ethics

§ According to local regulation. Centers self certify human subjects approval § Waiver of informed consent from participating institutions or central IRB § De-‐identified data with unique patient ID § HIPAA compliant database § A template of IRB application is available as needed (See appendix)

1 Table 1: Time-‐scheduled data that will be collected for each participating subject * You will receive a random 10-‐digit number for each patient that you register # BUN: Blood urea nitrogen

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Steering and advisory committees for Global Snapshot team Ravindra L. Mehta , San Diego, USA (Co-‐Chair of the Global Snapshot Team) Email: [email protected] Norbert Lameire, Gent, Belgium (Co-‐Chair of the Global Snapshot Team) Email: [email protected] Dwomoa Adu, Accra, Ghana Email: [email protected] Stuart Goldstein, Cincinnati, USA Email: [email protected] Adeera Levin, Vancouver, Canada Email: [email protected] Etienne Macedo, San Paolo, Brazil Email: [email protected] John Kellum, Pittsburg, USA Email: [email protected] Michael Joannidis, Innsbruck, Austria Email: michael.joannidis@i-‐med.ac.at Nattachai Srisawat, Bangkok, Thailand Email: [email protected] Melanie Godin, San Diego, USA Email: [email protected]

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Bibliography

1. Susantitaphong, P (2013). World incidence of AKI: a meta-‐analysis. Clin J Am Soc Nephrol, 8(9), 1482-‐93.

2. Kelllum, J (2012). Kidney attack. JAMA, 307(21), 2265-‐6.

3. Jha, V (2013). Community-‐acquired Acute Kidney Injury in Tropical Countries. Nat Rev Nephrol, 9, 278-‐290.

4. Lamiere, N (2013). Acute Kidney Injury: an Increasing global concern. Lancet,

13;382(9887),170-‐9.

5. Lewington, A (2013). Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int, 84(3),457-‐67.

protocol 09-04-14 › images › initiatives › global... · 0by25 an isn human rights initiative...

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