ISRCTN42955626
Confidential once completed Please answer all the questions
Investigator: …………………………………………… Centre: ……………………………………………….…….
Date of Birth:
D i i D i / M i i M i i M i / Y ii i Y ii i Y ii i Y ii Sex: Male iiL Female iiL
First Name: Surname:
NHS Number: iYii iYii iYii iYii iYii iYii iYii iYii iYii iYii
Title:
Patient Self-Declared Ethnicity:
I i I i
(Please refer to coded list, Note 1 page 2)
(To be eligible no shaded boxes must be ticked)
Patient has stage 3 CKD (GFR 30-59 mL/min/1.73 m 2 ) diagnosed using MDRD/CKD-EPI eGFR (at least two consecutive test results in this range at least 90 days apart, with the most recent test in the last 12 months)
Patient aged ≥18 years?
History of untoward reactions to iodinated contrast media or allergy to topical iodine
Episode of acute kidney injury in previous 6 months (as defined by the Acute Kidney Injury Network
Criteria – see Note 2 page 2)
Amputation of whole or part limb
Known current alcohol or drug abuse
No
Ii L i iiL ii
Ii L i
Ii L ii
Ii Lii
Yes iiL ii iiL ii iiL ii
Any clinical condition with an expected survival of less than study duration (3 years)
Able to comply with study schedule and follow-up
Does the patient have proteinuria? (ACR ≥30 mg/mmol or PCR ≥50 mg/mmol)
Does the patient have diabetes?
Ii L ii iiL ii
Ii Lii iiL ii
Ii Lii iiL ii
Ii L i iiL ii
Ii Lii iiL ii
Ii Lii iiL ii
Ii Lii iiL ii
Ii Lii iiL ii
Ii Lii iiL ii
Patient pregnant or breast feeding
Kidney transplant recipient?
Inability to provide informed consent e.g. due to cognitive impairment
Patient has given written informed consent (Version No: ……………………………………………..…….
)
Has the patient consented to: iiL No Joining the main study
Joining the 375 patient sub-study of disease progression? (Birmingham, Leicester and
London only)
Joining the 20 patient study of intra-individual biological variability? (Canterbury only)
iiL iiL
No
No iiL i iiL ii iiL iiL iiL
Yes
Yes
Yes
Has the patient consented to blood and urine samples being taken and stored for analysis of future biomarkers? iiL No iiL Yes eGFR-C - Registration Notepad Page 1 of 2 Version 1.2 9 th December 2014
ISRCTN42955626 Confidential once completed Please answer all the questions
Date of Registration:
D i i D i / M i i M i i M i / Y ii i Y ii i Y ii i Y ii
Study Number: ii I ii I ii I ii ii I ii
eGFR-C Online Registration and Data Entry: https://www.trials.bham.ac.uk/egfrc (24hrs) eGFR-C Telephone Registration: 0800 953 0274 (UK toll free) 9am to 5pm Mon-Fri. eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Public Health
Building, University of Birmingham, Birmingham, B15 2TT eGFR-C Study Website: http://www.birmingham.ac.uk/egfrc eGFR-C Study Mailbox: eGFR-C@trials.bham.ac.uk
31 White - English / Welsh / Scottish / Northern Irish / British
32 White - Irish
33 White - Gypsy or Irish Traveller
34 White - Any Other White background
35 Mixed / Multiple ethnic group - White and Black Caribbean
36 Mixed / Multiple ethnic group - White and Black African
37 Mixed / Multiple ethnic group - White and Asian
38 Mixed / Multiple ethnic group - Any Other Mixed / multiple ethnic background
39 Asian / Asian British – Indian
40 Asian / Asian British – Pakistani
41 Asian / Asian British – Bangladeshi
42 Asian / Asian British – Chinese
43 Asian / Asian British - Any other Asian background
44 Black / African / Caribbean / Black British – African
45 Black / African / Caribbean / Black British – Caribbean
46 Black / African / Caribbean / Black British – Any other Black / African / Caribbean background
47 Other ethnic group – Arab
48 Other ethnic group – Any other ethnic group
98 Any other
99 Not known/not provided
(AKIN criteria: Mehta R, Kellum J, Shah S, Molitoris B, Ronco C, Warnock D, Levin A, AKINetwork: Acute Kidney
Injury Network: Report of an Initiative to Improve Outcomes in Acute Kidney Injury Critical Care 2007 , 11:R31
(doi:10.1186/cc5713) online at: http://ccforum.com/content/11/2/R31 or download pdf: AKIN_ICC )
An abrupt (within 48 hours) reduction in kidney function currently defined as an absolute increase in serum creatinine of more than or equal to 26 umol/L, a percentage increase in serum creatinine of more than or equal to
50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours).
The above criteria include both an absolute and a percentage change in creatinine to accommodate variations related to age, gender, and body mass index and to reduce the need for a baseline creatinine but do require at least two creatinine values within 48 hours. The urine output criterion was included based on the predictive importance of this measure but with the awareness that urine outputs may not be measured routinely in nonintensive care unit settings. It is assumed that the diagnosis based on the urine output criterion alone will require exclusion of urinary tract obstructions that reduce urine output or of other easily reversible causes of reduced urine output. The above criteria should be used in the context of the clinical presentation and following adequate fluid resuscitation when applicable. Note: Many acute kidney diseases exist, and some (but not all) of them may result in acute kidney injury (AKI). Because diagnostic criteria are not documented, some cases of AKI may not be diagnosed. Furthermore, AKI may be superimposed on or lead to chronic kidney disease. eGFR-C - Registration Notepad Page 2 of 2 Version 1.2 9 th December 2014