North American Pediatric Renal Trials Collaborative Studies Production Release Registration (DEM) Web Version: 1.0; 1.
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1 Registration (DEM) Web Version: 1.0; 1.4; Does your site participate in the NAPRT CS Registries? 1- No 2- Yes 2. Date of birth: (mm/dd/yyyy) 3. Race/ethnicity: 4. Gender: 1-Male 2-Female 5. Primary renal diagnosis: If Other, specify diagnosis: 6. Biopsy or nephrectomy confirmation of diagnosis: 1-No 2-Yes 9-Unknown 7. Maternal Paternal Education Score: 8. Insurance Information: Does patient have Medicaid? 1-No 2-Yes 9-Unknown Does patient have supplemental private insurance? 1-No 2-Yes 9-Unknown 9. Has patient been transplanted prior to registration: 1-No 2-Yes 10. Total number of prior transplants: (x) 11. Has patient ever received maintenance dialysis? If Yes, specify date of first maintenance dialysis: (xx) Month/ (xxxx) Year 12. ABO (record for Transplant and Dialysis participants): 1-A 2-B 3-O 4-AB 13. Histocompatibility data of recipient Record for transplant participants: HLA-A A (xx) A (xx) HLA-B B (xx) B (xx) If assay performed but an allele was not determined, enter '99' HLA-DR DR (xx) DR (xx)
2 Additional Selection Options for DEM Primary renal diagnosis: Familial nephritis - Alport's Syndrome Cystinosis Oxalosis Congenital nephrotic syndrome Focal segmental glomerulosclerosis Membranoproliferative glomerulonephritis - Type I Membranoproliferative glomerulonephritis - Type II Membranous nephropathy Idiopathic crescentic glomerulonephritis Chronic glomerulonephritis Pyelonephritis/interstitial nephritis Reflux nephropathy SID w/sle nephritis SID w/henoch-schonlein purpura nephritis SID w/berger's nephritis (IgA) SID w/wegener's granulomatosis SID w/other Wilms' tumor Renal infarct Diabetic glomerulonephritis Sickle cell nephropathy Hemolytic uremic syndrome Drash syndrome Unknown Other, specify Education Score Maternal 5-5-Some college/ business/ vocational 6-6-College degree 7-7-Graduate work 9-9-Unknown
3 Patient Death (DTH) Web Version: 1.0; 1.1; Date of death: (mm/dd/yyyy) 2. Cause of death: If other, specify cause of death: 3. Graft status at death: 4. Comments:
4 Additional Selection Options for DTH Cause of death: Hemorrhage Recurrence of original renal disease Dialysis-related complications Other, specify Unknown
5 QIHDA (ENR) Web Version: 1.0; 1.0; QI-HD ENROLLMENT If a patient is already enrolled in a NAPRTCS Registry (CKD, Dialysis or Transplant) or the patient is already enrolled in QI-PD you MUST use the same Participant ID to enroll the participant. 1-New HD participant is a participant not on Hemodialysis immediately before receiving the insertion/creating access for this enrollment. The enrollment date is the out-patient dialysis start date for this insertion/creation access and is between the date your site began participation in this study (or 06/01/13 when CHA began the study) and today. 2-Prevalent participant is a participant currently on out-patient Hemodialysis prior to the start of this study. The enrollment date is the date your site began participation in this study (or 06/01/2013 when CHA began the study). 3-New transfer participant is a participant that has been transferred to your center from a non-naprtcs facility. If a participant is transferred to your facility from a NAPRTCS facility, please contact the data coordinating center before entering into the database. The enrollment date for a new transfer participant is the date the participant is transferred to your center and is between the date your site began participation in this study (or 06/01/2013 when CHA began the study) and today. 1. Enrollment Date: (mm/dd/yyyy) 2. Enrollment Date: (mm/dd/yyyy) At Enrollment, also complete a Primary Access Form and Follow-up Form If participating in NAPRTCS, please enroll in Dialysis Registry
6 Registry Sequence: Visit Date: QI-HD - Hemodialysis Catheter Maintenance Observation Form (HCM) Web Version: 1.0; 1.0; A. Access Type 1. Access Type: B. HD Catheter Dressing/Site Assessment 1. Dressing present? 0-No dressing 1-Yes 2. Clean, dry, intact & never submerged in water? 0- No 1- Yes 3. Dressing date clear? 0- No 1- Yes C. HD Catheter Connection/Entry 1. Proper hand hygiene performed? 0- No 1- Yes 2. Clean gloves worn for all catheter entries? 0- No 1- Yes 3. Face protection used by provider/assistant? 0- No 1- Yes 4. Mask fo r p atie nt? 0- No 1- Yes 5. Cap/hub disinfected? 0- No 1- Yes a. If disinfected, indicate the disinfection method used: (Choose one) 6. Tubing connected using aseptic technique? 0- No 1- Yes 7. Removed gloves and performed proper hand hygiene? 0- No 1- Yes D. HD Catheter Disconnection 1. Proper hand hygiene performed? 0- No 1- Yes 2. Clean gloves worn? 0- No 1- Yes 3. Face protection used by provider/assistant? 0- No 1- Yes 4. Mask fo r p atie nt? 0- No 1- Yes 5. Disconnect using aseptic technique? 0- No 1- Yes 6. Cap/Hub disinfected? 0- No 1- Yes Indicate disinfection used (choose one):
7 7. Removed gloves and proper hand hygiene performed? 0- No 1- Yes E. Cap Care 1. Type of cap: 1-Closed connector luer access cap 2-Standard cap a. Old cap date/time clear? 0- No 1- Yes b. New cap date/time clear? 0 -No 1 -Yes 98-N/A 2. Cap changed? 0- No 1- Yes a. Reason cap NOT changed: Cap change due, but not changed: Explain why: F. HD Catheter Dressing Change and Exit Site Care Procedure 1. Proper hand hygiene performed? 0- No 1- Yes 2. Clean gloves worn? 0- No 1- Yes 3. Face protection used by provider/assistant? 0- No 1- Yes 4. Mask fo r p atie nt? 0- No 1- Yes 5. Was antiseptic applied to exit site and allowed to dry? 0- No 1- Yes If YES, choose one) 6. Was antimicrobial ointment/cream applied to exit site? 0- No 1- Yes If YES, choose one 7. Removed gloves and proper hand hygiene performed? 0- No 1- Yes G. A/V Fistula / Graft Care & Cannulation 1. Who is accessing fistula or graft? 1-Patient 2-Staff 2. Patient site washed with soap and water? 0- No 1- Yes 3. Proper hand hygiene performed? 0- No 1- Yes 4. Clean gloves worn? 0- No 1- Yes 5. Face protection used by provider/assistant? 0- No 1- Yes 6. Mask fo r p atie nt? 0- No 1- Yes 7. Antiseptic applied and allowed to dry? 0- No 1- Yes If Yes, indicate antiseptic used:
8 8. Needles inserted using aseptic technique? 0- No 1- Yes 9. Removed gloves and performed proper hand hygiene? 0- No 1- Yes H. A/V Fistula / Graft Decannulation 1. Who is performing decannulation? 1-Patient 2-Staff 2. Proper hand hygiene performed? 0- No 1- Yes 3. Clean gloves worn? 0- No 1- Yes 4. Face protection worn by provider/assistant? 0- No 1- Yes 5. Mask for patient from cannulation site? 0- No 1- Yes 6. Needles removed using aseptic technique? 0- No 1- Yes 7. Applied clean gauze/bandage to site? 0- No 1- Yes 8. Compressed the site with clean gloves? 0- No 1- Yes 9. Removed gloves and performed proper hand hygiene? 0- No 1- Yes Comments:
9 Registry Sequence: Event Date: QI-HD - Hemodialysis Event (HDE) Web Version: 1.0; 1.0; A. Event Details 1. Which events (or infections) occurred on this date? a. Positive blood culture 0- No 1- Yes b. Access site infection 0- No 1- Yes B. Positive Blood Culture 1. Site(s) from which positive blood culture(s) were obtained (choose all that apply): HD catheter port Blue 0- No 1- Yes HD catheter port Red 0- No 1- Yes Non-dialysis catheter or port 0- No 1- Yes Fistula/Graft 0- No 1- Yes Peripheral 0- No 1- Yes a. Were negative blood culture(s) obtained on the same day as the positive blood culture(s)? (If YES, choose all that apply) 0- No 1- Yes HD catheter port Blue 0- No 1- Yes HD catheter port Red 0- No 1- Yes Non-dialysis catheter or port 0- No 1- Yes Fistula/Graft 0- No 1- Yes Peripheral 0- No 1- Yes 2. Is there clinical evidence of infection other than the positive blood culture? 0- No 1- Yes If yes, please specify site: Wound (NOT related to vascular access) with pus or increased redness 0- No 1- Yes Cellutitis (skin redness, heat or pain without open wound) 0- No 1- Yes Pneumonia or respiratory infection 0- No 1- Yes Urinary tract infection 0- No 1- Yes Graft/fistula access site 0- No 1- Yes O the r ( spe cify ): 0- No 1- Yes a. Did a culture from this site(s) show the same organism found in the blood culture? 0-No 1-Yes 2-No culture obtained 3. Specify signs/symptoms noted when the initial blood culture was obtained: Are there signs/symptoms 0- No 1- Yes Fe ve r >37.8 C (100 F) oral 0- No 1- Yes Drop in blood pressure 0- No 1- Yes Chills or rigors 0- No 1- Yes
10 Other problem: 0- No 1- Yes 4. Specify organism(s) a. For each organism, indicate number of positive blood cultures: Staphylococcus coagulase-negative 0-None 1 >2 Enterococcus faecalis 0-None 1 >2 Enterococcus faecium 0-None 1 >2 Staphylococcus aureus MRSA 0-None 1 >2 Staphylococcus aureus non-mrsa 0-None 1 >2 Acinetobacter spp. (specify) 0-None 1 >2 Specify: Escherichia coli 0-None 1 >2 If E. Coli, ESBL positive? 0- No 1- Yes Enterobacter spp. 0-None 1 >2 Klebsiella spp 0-None 1 >2 If Klebsiella spp, ESBL positive? 0- No 1- Yes Serratia marcescens 0-None 1 >2 Pseudomonas aeruginosa 0-None 1 >2 Stenotrophomonas maltophilia 0-None 1 >2 Other gram negative (specify): 0-None 1 >2 Specify: Fungus (specify): 0-None 1 >2 Specify: Other (specify): 0-None 1 >2 Specify: Other (specify): 0-None 1 >2 Specify: 5. In addition to antibiotics, which interventions took place? Catheter re-wired 0- No 1- Yes Temporary removal of catheter 0- No 1- Yes Permanent removal of catheter 0- No 1- Yes Revision of graft/fistula 0- No 1- Yes Permanent removal of graft/fistula 0- No 1- Yes Other: 0- No 1- Yes 6. What was the outcome of the positive blood culture? 1-Resolution 2-Death 99-Other C. Access Site Infection 1. Check the assess site(s) with infection:
11 Fistula: 0- No 1- Yes Graft: 0- No 1- Yes Tunneled central line: 0- No 1- Yes Non-tunneled central line: 0- No 1- Yes Other access device: 0- No 1- Yes 2. Was this a central line access site infection, if yes, provide exit site score: 0- No 1- Yes Swelling: 0-No 1-Exit only (<05cm) 2-Part of or entire tunnel Crust: 0-No 1- <0.5cm 2- >0.5cm Redness: 0-No 1- <0.5cm 2- >0.5cm Pressure pain: 0-No 1-Slight 2-Severe Secretion: 0-No 1-Clear 2-Purulent TOTAL Score: (xx) 3. Was culture obtained? 0- No 1- Yes Please specify: Culture was negative 0- No 1- Yes Staph aureus MRSA 0- No 1- Yes Staph aureus non-mrsa 0- No 1- Yes Pseudomonas aeuginosa 0- No 1- Yes Other 0- No 1- Yes If other specify: 4. In addition to antibiotics, which interventions took place? Catheter re-wired 0- No 1- Yes Temporary removal of catheter 0- No 1- Yes Permanent removal of catheter 0- No 1- Yes Revision of graft/fistula 0- No 1- Yes Permanent removal of graft/fistual 0- No 1- Yes Other 0- No 1- Yes 5. What was outcome of this infection (choose one): 1-Resolution 2-Death 99-Other D. Hospitalization 1. Has patient been admitted to hospital as a result of this event? 0- No 1- Yes a. Length of hospital day: (xxxx) (days) 2. Did the event occur during a hospital stay? 0- No 1- Yes a. Did non-dialysis staff access the hemodialysis access? 0- No 1- Yes Comments:
12 Registry Sequence: QI-HD Hemodialysis Termination (HDT) Web Version: 1.0; 1.0; Date of Termination Event: (mm/dd/yyyy) 2. Termination Event: 3. Reason for discontinuation of Hemodialysis: Comments:
13 Registry Sequence: Visit Date: QI-HD - Hemodialysis Follow-Up Form (HFF) Web Version: 1.0; 1.0; A. Access Type 1. Access Type: B. HD Catheter Access/Exit Site Care 1. Since the last follow-up, which of the following was most commonly used to scrub the catheter hub prior to connection and after disconnection? (Choose one) 2. Which agent was most commonly used to cleanse the exit site? 3. What type of dressing was used? 4. How frequently is dressing changed? 5. Is antimicrobial ointment/cream routinely applied to the exit site dur ing dressing change? 0- No 1- Yes
14 a. If antimicrobial ointment/cream used, indicate type (Choose one) 6. Are any of the following used in this patient? a. Antimicrobial-impregnated hemodialysis catheters 0- No 1- Yes b. Closed connector luer access devices 0- No 1- Yes c. Antimicrobial lock solutions 0- No 1- Yes 7. If Antimicrobial lock solution, indicate the lock solutions used?: a. Sodium citrate 0- No 1- Yes b. Gentamicin 0- No 1- Yes c. Va nco mycin 0- No 1- Yes d. Taurolidine 0- No 1- Yes e. Ethanol 0- No 1- Yes f. Other: 0- No 1- Yes C. AV Fistula or Graft Access/Care 1. Before prepping the area for puncture, is the area routinely washed with soap and water? 0- No 1- Yes 2. Before puncture of a graft or fistula, the area is routinely prepped with: 3. Who routinely accesses the site? (Choose one) 1-Nurse 2-Technician 3-Patient 99-Other 4. Is buttonhole cannulation performed? 0- No 1- Yes a. If buttonhole cannulation performed, is antibiotic ointment/cream applied after each dialysis session? 0- No 1- Yes b. If antibiotic ointment/cream applied, indicate type: Comments:
15 Registry Sequence: Ac ce ss Creation Da te : QI-HD - Primary Access Creation or Revision Form (HPA) Web Version: 1.0; ; Complete when primary access type changes & upon enrollment. A. Primary Access Type 1. Type of primary access: 2. Date primary access first used for dialysis: (mm/dd/yyyy) B. Catheter Insertion Data 1. Type of Catheter: 1-Tunneled 2-Non-tunneled 99-Other 2. Location of Catheter: 3. Catheter insertion procedure performed: 1-Operating Room 2-Interventional Radiology 99-Other Comments:
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