Intensive versus Conventional Renal Support in Acute Renal Failure

Not Applicable

Completed

• Conditions: Acute Renal Failure; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000044022
• Lead Sponsor: S Department of Veterans Affairs Cooperative Studies Program

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1164

Inclusion Criteria

1. Acute renal failure (ARF) clinically consistent with a diagnosis of acute tubular necrosis (ATN), defined as: clinical setting of acute ischemic or nephrotoxic injury; and oliguria (average urine output < 20 mL/hr) for > 24 hours or an increase in serum creatinine of at least 2.0 mg/dL (men)/1.5 mg/dL (women) over a period of no more than 4 days

2. Plan for renal replacement therapy

3. Receiving care in critical care unit

4. At least one non-renal organ failure (Sequential Organ Function Assessment organ system score of at least 2) or the presence of sepsis

5. Age of at least 18 years

6. Informed consent

Exclusion Criteria

1. Baseline chronic kidney disease (CKD) defined by serum creatinine > 2 mg/dL (men) / 1.5 mg/dL (women)

2. Acute renal failure (ARF) due to an etiology other than acute tubular necrosis (ATN)

3. More than 72 hours since meeting BOTH of the following: Definition of ARF as specified in the inclusion criteria and a blood urea nitrogen (BUN) > 100 mg/dL

4. More than 1 hemodialysis treatment or more than 24 hours of continuous renal replacement therapy (CRRT)

5. History of kidney transplantation

6. Weight > 128.5 kg

7. Pregnancy

8. Prisoner

9. Non-candidacy for renal replacement therapy (RRT)

10. Not expected to survive 28-days due to underlying chronic medical condition

11. Moribund sate or comfert measures only (CMO) status

12. Participation in a concurrent interventional trial

13. Patient refusal

14. Physician refusal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality as assessed from medical records[60 days following randomization]

Secondary Outcome Measures

Name	Time	Method
Recovery of renal function defined as a measured creatinine clearance of > 20 mL/min[28 days after randomization];All-cause in-hosptial mortality assessed from hospital medical records[60 days following randomisation];All-cause mortality assessed from follow-up telephone interview and/or vital status registry[1 year following randomization]