ID

16046

Beschreibung

NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Stichworte

Versionen (1)
  1. 27.06.16 27.06.16 -
Hochgeladen am

27. Juni 2016

DOI

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Renal Replacement Therapy RICH study NCT02669589

Englisch

Renal Replacement Therapy RICH study NCT02669589

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
ID of Center
Beschreibung

Center ID

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
ID of patient
Beschreibung

Patient ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Dialysis information
Beschreibung

Dialysis information

Alias
UMLS CUI-1
C0011946
Code list number for Filter number: (Codes can be used several times)
Beschreibung

Dialysis Filter Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0491067
UMLS CUI [1,2]
C0237753
Filter Start Date:
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Filter Start Time:
Beschreibung

Start Time

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Code list for Dialysis machine:
Beschreibung

Dialysis machine

Datentyp

text

Alias
UMLS CUI [1]
C3489407
Code list for Modality:
Beschreibung

Modality

Datentyp

text

Code list Filter:
Beschreibung

Filter

Datentyp

text

Alias
UMLS CUI [1]
C0491067
Filter replacement?
Beschreibung

Filter replacement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0491067
UMLS CUI [1,2]
C0559956
If filter replacement, specify reason:
Beschreibung

Filter replacement: Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0491067
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0392360
Filter End Date:
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Filter End Time:
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Addition of Citrate Antikoagulation:
Beschreibung

Citrate Antikoagulation

Datentyp

text

Alias
UMLS CUI [1,1]
C0376259
UMLS CUI [1,2]
C0003281
Addition of Heparin Antikoagulation:
Beschreibung

Heraprin Antikoagulation

Datentyp

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0003281
Code List for Complications of Renal Replacment Therapy:
Beschreibung

Complications of RRT

Datentyp

text

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0206074
Dialysis flow (at least 3 times each day at department AND at least once each shift (+/- 1h) - representing actual state)
Beschreibung

Dialysis flow (at least 3 times each day at department AND at least once each shift (+/- 1h) - representing actual state)

Alias
UMLS CUI-1
C2030564
Point in time: Measurement
Beschreibung

Point in time

Datentyp

text

Alias
UMLS CUI [1]
C0439547
Temperature adjustment of dialyisis machine:
Beschreibung

Temperature dialysis machine

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C3489407
°C
Dialysis flow rate:
Beschreibung

Dialysis flow rate

Datentyp

float

Maßeinheiten
  • mL/h
Alias
UMLS CUI [1]
C2030564
mL/h
Citrate flow: (dose in mmol per Shift)
Beschreibung

Citrate flow

Datentyp

float

Maßeinheiten
  • mmol/shift
Alias
UMLS CUI [1,1]
C0008857
UMLS CUI [1,2]
C0806140
mmol/shift
Calcium substitution: (dose in mmol per shift)
Beschreibung

Calcium substitution

Datentyp

float

Maßeinheiten
  • mmol/shift
Alias
UMLS CUI [1,1]
C0006675
UMLS CUI [1,2]
C1706204
mmol/shift
Flow of substituition:
Beschreibung

Flow of substituition

Datentyp

float

Maßeinheiten
  • mL/h
Alias
UMLS CUI [1,1]
C1706204
UMLS CUI [1,2]
C0806140
mL/h
Extra-corporal Calcium post-Filter
Beschreibung

Extra-corporal Calcium post-Filter

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1,1]
C0006675
UMLS CUI [1,2]
C0491067
UMLS CUI [1,3]
C0015354
mmol/L
Blood flow:
Beschreibung

Blood flow

Datentyp

text

Maßeinheiten
  • mL/min
Alias
UMLS CUI [1]
C0005776
mL/min
Ultrafiltration rate:
Beschreibung

Ultrafiltration rate

Datentyp

float

Maßeinheiten
  • mL/h
Alias
UMLS CUI [1]
C0811696
mL/h
Time: interruption: (e.g. Operations, transport to CT)
Beschreibung

Time: interruption

Datentyp

float

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0443239
UMLS CUI [1,2]
C0040223
min
Patient withdrawal:
Beschreibung

Patient withdrawal

Datentyp

text

Maßeinheiten
  • mL/h
Alias
UMLS CUI [1]
C2825032
mL/h
Catheter: Adjustment
Beschreibung

Catheter: Adjustment

Alias
UMLS CUI-1
C0085590
UMLS CUI-2
C0456081
Start Date Catheter
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Start time Catheter:
Beschreibung

Start Time

Datentyp

time

Alias
UMLS CUI [1]
C1301880
End Date Catheter:
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
End Time Catheter:
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Type of Catheter:
Beschreibung

Type of Catheter

Datentyp

text

Alias
UMLS CUI [1,1]
C0085590
UMLS CUI [1,2]
C0332307
Codelist for Catheter diameter:
Beschreibung

Catheter diameter

Datentyp

text

Alias
UMLS CUI [1]
C1315910
Codelist for Catheter diameter: If "other", specify:
Beschreibung

Catheter diameter specifciation

Datentyp

float

Alias
UMLS CUI [1,1]
C1315910
UMLS CUI [1,2]
C2348235
Codelist for Catheter length:
Beschreibung

Catheter length

Datentyp

text

Alias
UMLS CUI [1]
C0449463
Codelist for Catheter length: If "other", specify:
Beschreibung

Catheter length Specification

Datentyp

float

Alias
UMLS CUI [1,1]
C0449463
UMLS CUI [1,2]
C2348235
Codelist for Location of Catheter:
Beschreibung

Location of Catheter

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0085590
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Ähnliche Modelle

Renal Replacement Therapy RICH study NCT02669589

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of patient
text
C2348585 (UMLS CUI [1])
Item Group
Dialysis information
C0011946 (UMLS CUI-1)
Item
Code list number for Filter number: (Codes can be used several times)
text
C0491067 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Dialysis Filter Number
Code List
Code list number for Filter number: (Codes can be used several times)
CL Item
Filter 1 start until ≤ 24h (1)
CL Item
Filter 1 > 24h ≤ 48h (2)
CL Item
Filter 1 > 48 ≤ 72h (3)
CL Item
Filter 2 start until ≤ 24h (4)
CL Item
Filter 2 > 24h ≤ 48h (5)
CL Item
Filter 2 > 48 ≤ 72h (6)
CL Item
Filter 3 start until ≤ 24h (7)
CL Item
Filter 3 > 24h ≤ 48h (8)
CL Item
Filter 3 > 48 ≤ 72h (9)
CL Item
Filter 4 start until ≤ 24h (10)
CL Item
Filter 4 > 24h ≤ 48h (11)
CL Item
Filter 4 > 48 ≤ 72h (12)
CL Item
Filter 5 start until ≤ 24h (13)
CL Item
Filter 5 > 24h ≤ 48h (14)
CL Item
Filter 5 > 48 ≤ 72h (15)
CL Item
Filter 6 start until ≤ 24h (16)
CL Item
Filter 6 > 24h ≤ 48h (17)
CL Item
Filter 6 > 48 ≤ 72h (18)
CL Item
Filter 7 start until ≤ 24h (19)
CL Item
Filter 7 > 24h ≤ 48h (20)
CL Item
Filter 7 > 48 ≤ 72h (21)
CL Item
Filter 8 start until ≤ 24h (22)
CL Item
Filter 8 > 24h ≤ 48h (23)
CL Item
Filter 8 > 48 ≤ 72h (24)
CL Item
Filter 9 start until ≤ 24h (25)
CL Item
Filter 9 > 24h ≤ 48h (26)
CL Item
Filter 9 > 48 ≤ 72h (27)
CL Item
Filter 10 start until ≤ 24h (28)
CL Item
Filter 10 > 24h ≤ 48h (29)
CL Item
Filter 10 > 48 ≤ 72h (30)
Start Date
Item
Filter Start Date:
date
C0808070 (UMLS CUI [1])
Start Time
Item
Filter Start Time:
time
C1301880 (UMLS CUI [1])
Item
Code list for Dialysis machine:
text
C3489407 (UMLS CUI [1])
Dialysis machine
Code List
Code list for Dialysis machine:
CL Item
Multifiltrate, FMC (1)
CL Item
Prismaflex, Gambro (2)
Item
Code list for Modality:
text
Modality
Code List
Code list for Modality:
CL Item
CVVH (1)
CL Item
CVVHD (2)
CL Item
CVVHDF (3)
Item
Code list Filter:
text
C0491067 (UMLS CUI [1])
Filter
Code List
Code list Filter:
CL Item
ST100 (1)
CL Item
AV 1000 S (2)
CL Item
AV600S (3)
CL Item
AV1000 (4)
CL Item
AV100 (5)
CL Item
100DS (6)
CL Item
1400 (7)
CL Item
M150 (8)
Filter replacement
Item
Filter replacement?
boolean
C0491067 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
Item
If filter replacement, specify reason:
text
C0491067 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Filter replacement: Reason
Code List
If filter replacement, specify reason:
CL Item
clotting (01)
CL Item
filter replacement after 72h (02)
CL Item
conversion of process (03)
CL Item
recovery of renal function (04)
CL Item
death of patient (05)
End Date
Item
Filter End Date:
date
C0806020 (UMLS CUI [1])
End Time
Item
Filter End Time:
time
C1522314 (UMLS CUI [1])
Item
Addition of Citrate Antikoagulation:
text
C0376259 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Citrate Antikoagulation
Code List
Addition of Citrate Antikoagulation:
CL Item
Calcium chloride 1 N (0,5 mol) (1)
CL Item
not used (2)
Item
Addition of Heparin Antikoagulation:
text
C0019134 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Citrate Antikoagulation
Code List
Addition of Heparin Antikoagulation:
CL Item
Multifiltrat Kit4 (1)
CL Item
Liquemin (2)
CL Item
Multibic (3)
CL Item
not used (4)
Item
Code List for Complications of Renal Replacment Therapy:
text
C0009566 (UMLS CUI [1,1])
C0206074 (UMLS CUI [1,2])
Complications of RRT
Code List
Code List for Complications of Renal Replacment Therapy:
CL Item
no complications (1)
CL Item
First use reaction (2)
CL Item
Hypotension with discontinuation (3)
CL Item
air embolism (4)
CL Item
haemorrhage (5)
CL Item
new severe arrythmyia (6)
CL Item
iatrogenic fluid and electrolyte imbalance (7)
CL Item
seizure (8)
CL Item
problems with inserting catheter (9)
Item Group
Dialysis flow (at least 3 times each day at department AND at least once each shift (+/- 1h) - representing actual state)
C2030564 (UMLS CUI-1)
Item
Point in time: Measurement
text
C0439547 (UMLS CUI [1])
Point in time
Code List
Point in time: Measurement
CL Item
early shift (1)
CL Item
late shift (2)
CL Item
night shift (3)
Temperature dialysis machine
Item
Temperature adjustment of dialyisis machine:
float
C0039476 (UMLS CUI [1,1])
C3489407 (UMLS CUI [1,2])
Dialysis flow rate
Item
Dialysis flow rate:
float
C2030564 (UMLS CUI [1])
Citrate flow
Item
Citrate flow: (dose in mmol per Shift)
float
C0008857 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
Calcium substitution
Item
Calcium substitution: (dose in mmol per shift)
float
C0006675 (UMLS CUI [1,1])
C1706204 (UMLS CUI [1,2])
Flow of substituition
Item
Flow of substituition:
float
C1706204 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
Extra-corporal Calcium post-Filter
Item
Extra-corporal Calcium post-Filter
float
C0006675 (UMLS CUI [1,1])
C0491067 (UMLS CUI [1,2])
C0015354 (UMLS CUI [1,3])
Blood flow
Item
Blood flow:
text
C0005776 (UMLS CUI [1])
Ultrafiltration rate
Item
Ultrafiltration rate:
float
C0811696 (UMLS CUI [1])
Time: interruption
Item
Time: interruption: (e.g. Operations, transport to CT)
float
C0443239 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Patient withdrawal
Item
Patient withdrawal:
text
C2825032 (UMLS CUI [1])
Item Group
Catheter: Adjustment
C0085590 (UMLS CUI-1)
C0456081 (UMLS CUI-2)
Start Date
Item
Start Date Catheter
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start time Catheter:
time
C1301880 (UMLS CUI [1])
End Date
Item
End Date Catheter:
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time Catheter:
time
C1522314 (UMLS CUI [1])
Item
Type of Catheter:
text
C0085590 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Catheter
Code List
Type of Catheter:
CL Item
2 lumen (1)
CL Item
3 lumen (2)
Item
Codelist for Catheter diameter:
text
C1315910 (UMLS CUI [1])
Catheter diameter
Code List
Codelist for Catheter diameter:
CL Item
11 French (11)
CL Item
12 French (12)
CL Item
13 French (13)
CL Item
Other (Other)
Catheter diameter specifciation
Item
Codelist for Catheter diameter: If "other", specify:
float
C1315910 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Codelist for Catheter length:
text
C0449463 (UMLS CUI [1])
Catheter length
Code List
Codelist for Catheter length:
CL Item
150 mm (150)
CL Item
175 mm (175)
CL Item
200 mm (200)
CL Item
240 mm (240)
CL Item
Other (Other)
Catheter length Specification
Item
Codelist for Catheter length: If "other", specify:
float
C0449463 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Codelist for Location of Catheter:
text
C1515974 (UMLS CUI [1,1])
C0085590 (UMLS CUI [1,2])
Location of Catheter
Code List
Codelist for Location of Catheter:
CL Item
V. jugularis (1)
CL Item
V. subclavia (2)
CL Item
V. femoralis (3)
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