Renal Replacement Therapy aCRF

Illustrates Domains

Illustrates Variables

PRMEDIND
PRREASOC
PRTRT
PRINDC
PRRSDISC

Content

This CRF provides examples of drop-down lists that may be used. Depending on the needs of the study, the sponsor may use other responses. The questions displayed are controlled by EDC navigation. This navigation is not illustrated in the form.

CRF Instructions

Record whether renal replacement therapy (RRT) was medically indicated for acute renal disease. If medically indicated, complete the rest of the form.

If RRT was given, record each intervention on an individual line. If the subject is receiving a fixed schedule of intermittent RRT (e.g., 3x/week), record this as 1 line and specify the frequency. If a subject is receiving intermittent RRT that is not administered on a fixed schedule, record each session separately. The start and end times should be provided for any intermittent therapy.

If RRT was not given, record the reason it was not administered.

	Procedure Category PRCAT Hidden/pre-populated	RENAL REPLACEMENT THERAPY
Indicate whether RRT therapy was medically indicated. If medically indicated, complete the rest of this form.	Was RRT medically indicated for acute kidney disease? PRMEDIND NSPR.PRMEDIND where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"	Yes No <From NY codelist>
Indicate whether the subject received RRT.	Has the subject received RRT? PROCCUR PROCCUR where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"	Yes No <From NY codelist>
Record the reason RRT was not administered.	If RRT was indicated but not administered, what was the reason it was not administered? PRREASOC NSPR.PRREASOC where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"	Subject refuses RRT not available Provider felt RRT was futile Other, specify
Record the other reason RRT was not administered.	Specify Other PRREASOCOTH NSPR.PRREASOC	_________________
Record the type of RRT.	What was the type of RRT? PRTRT	Intermittent hemodialysis Prolonged intermittent renal replacement therapy Continuous renal replacement therapy (CRRT) Peritoneal dialysis
Record the reason RRT was indicated.	What was the indication for RRT? PRINDC	Fluid overload Hyperkalemia Metabolic acidosis Other, specify
Record the start date using this format (DD-MON-YYYY).	Start Date PRSTDAT PRSTDTC	_ _ / _ _ _ / _ _ _ _
If No, complete end date and reason discontinued.	Is the RRT ongoing? PRONGO PRENRTPT="ONGOING"	Yes <From NY codelist>
	End Timepoint PRENTPT Hidden/pre-populated	Sponsor-defined
Record the end date of RRT using this format (DD-MON-YYYY).	End Date PRENDAT PRENDTC	_ _ / _ _ _ / _ _ _ _
Record the primary reason RRT was discontinued.	What was the reason for discontinuation? PRRSDISC	Recovered kidney function Subject refuses to continue Other

View CRF Metadata

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Variable Mapping	Controlled Terminology Code List Name	CRF Implementation Notes	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	PRCAT	Procedure category	Procedure Category		Text	PRCAT			The category was obtained from the CRF title.		RENAL REPLACEMENT THERAPY			yes
2	PRMEDIND	Was RRT medically indicated for acute kidney disease?		Indicate whether RRT therapy was medically indicated. If medically indicated, complete the rest of this form.	Text	NSPR.PRMEDIND	NSPR.PRMEDIND where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"	(NY)		Yes;No			radio
3	PROCCUR	Has the subject received RRT?	Occurrence	Indicate whether the subject received RRT.	Text	PROCCUR	PROCCUR where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"	(NY)		Yes;No			radio
4	PRREASOC	If RRT was indicated but not administered, what was the reason it was not administered?	Reason For Occurrence	Record the reason RRT was not administered.	Text	NSPR.PRREASOC	NSPR.PRREASOC where PRTRT="RENAL REPLACEMENT THERAPY" and PRINDC="ACUTE KIDNEY DISEASE"		The permissible values used would be study-specific.	Subject refuses; RRT not available; Provider felt RRT was futile; Other, specify
5	PRREASOCOTH	Specify Other	Other Reason For Occurrence	Record the other reason RRT was not administered.	Text	NSPR.PRREASOC
6	PRTRT	What was the type of RRT?	Procedure Name	Record the type of RRT.	Text	PRTRT			The permissible values used would be study-specific.	Intermittent hemodialysis; Prolonged intermittent renal replacement therapy; Continuous renal replacement therapy (CRRT); Peritoneal dialysis			radio
7	PRINDC	What was the indication for RRT?	Indication	Record the reason RRT was indicated.	Text	PRINDC			The permissible values used would be study-specific.	Fluid overload;Hyperkalemia; Metabolic acidosis;Other, specify
8	PRSTDAT	What was the start date?	Start Date	Record the start date using this format (DD-MON-YYYY).	Date	PRSTDTC						prompt
9	PRONGO	Is the RRT ongoing?	Ongoing	If No, complete end date and reason discontinued.	Text	PRENRTPT="ONGOING"		(NY)		Yes			radio
10	PRENTPT	N/A	End Timepoint	Record the end timepoint.	Text	PRENTPT					Sponsor-defined			yes
11	PRENDAT	What was the end date?	End Date	Record the end date of RRT using this format (DD-MON-YYYY).	Date	PRENDTC						prompt
12	PRRSDISC	What was the reason for discontinuation?	Reason Discontinued	Record the primary reason RRT was discontinued.	Text	PRRSDISC			The permissible values used would be study-specific. The other reason was not collected.	Recovered kidney function; Subject refuses to continue; Other