Renal Replacement Therapy

Illustrates Domains

Illustrates Variables

PRTRT
PRDECOD
PRINDC
PRRSDISC
PRMEDIND
PRREASOC

Content

This is an example showing RRT for subjects with acute renal failure. The protocol defined general medical criteria for the initiation of RRT, but allowed for investigator discretion as to whether RRT was administered. The reason medically indicated RRT, as defined in the protocol, was not administered or was discontinued is shown. RRT may be withheld because of advanced age or in circumstances where no benefit is expected.

RRT is considered a procedure and is represented in the Procedures (PR) domain. The sponsor used the Medical Dictionary for Regulatory Activities (MedDRA) to determine the PRDECOD. PRINDC was used to represent the specific condition that resulted in RRT. Non-standard variables (NSVs) were used to record the reason RRT was not given (NSPR.PRREASOC) and whether RRT was medically indicated (NSPR.PRMEDIND), as described in the protocol.

pr.xpt

Rows 1-2:	Show the subject had medically indicated RRT, as defined in the protocol. The subject underwent hemofiltration due to metabolic acidosis. The reason for discontinuation was "Other".
Rows 3-4:	Show the subject had medically indicated RRT, as defined in the protocol. The subject underwent hemodialysis, which was ongoing as of the last update provided by the investigator. This update was provided at the 120-day follow-up visit. This date is represented in PRENTPT.
Rows 5-6:	Show the subject had medically indicated RRT, as defined in the protocol. The subject underwent CRRT. After the subject recovered kidney function, RRT was ended.
Row 7:	Shows the subject did not undergo RRT. The therapy was medically indicated, but not administered.
Row 8:	Shows the subject did not undergo RRT. The therapy was medically indicated, but not administered.
Row 9:	Shows the subject did not undergo RRT, because it was not medically indicated.

pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRGRPID	PRTRT	PRDECOD	PRCAT	PRPRESP	PROCCUR	PRINDC	PRRSDISC	PRDTC	PRSTDTC	PRENDTC	PRENRTPT	PRENTPT	PRMEDIND	PRREASOC
1	XYZ-001	PR	XYZ-001-001	1	1	Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	Y	ACUTE KIDNEY DISEASE		2013-11-30					Y
2	XYZ-001	PR	XYZ-001-001	2	1	Intermittent Hemodialysis	Haemofiltration	RENAL REPLACEMENT THERAPY			METABOLIC ACIDOSIS	Other		2013-10-29	2013-11-02
3	XYZ-001	PR	XYZ-001-002	1	1	Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	Y	ACUTE KIDNEY DISEASE		2015-03-20					Y
4	XYZ-001	PR	XYZ-001-002	2	1	Intermittent Hemodialysis	Haemodialysis	RENAL REPLACEMENT THERAPY			FLUID OVERLOAD			2015-03-11		ONGOING	2015-07-8
5	XYZ-001	PR	XYZ-001-003	1	1	Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	Y	ACUTE KIDNEY DISEASE		2010-10-12					Y
6	XYZ-001	PR	XYZ-001-003	2	1	Continuous Renal Replacement Therapy (CRRT)	Haemodialysis	RENAL REPLACEMENT THERAPY			HYPERKALEMIA	Recovered kidney function		2010-09-12	2015-09-16
7	XYZ-001	PR	XYZ-001-004	1		Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	N	ACUTE KIDNEY DISEASE		2015-03-27					Y	RRT not available
8	XYZ-001	PR	XYZ-001-005	1		Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	N	ACUTE KIDNEY DISEASE		2015-11-27					Y	Provider felt RRT was futile
9	XYZ-001	PR	XYZ-001-005	2		Renal Replacement Therapy	Renal replacement therapy	RENAL REPLACEMENT THERAPY	Y	N	ACUTE KIDNEY DISEASE		2015-11-27					N

PR NSV Metadata

Variable	Label	Type	Role	Origin
PRREASOC	Reason for Occurrence Value	text	Non-Standard Record Qualifier	CRF
PRMEDIND	Medically Indicated Intervention	text	Non-Standard Record Qualifier	CRF