Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: Inclusion Criteria:

1. Adult patients (over 16 years of age) admitted to a participating ICU
2. Serum creatinine increase of ≥ 50% from baseline
3. Hemodynamic instability as defined by the cardiovascular component of the SOFA score of ≥ 1
4. Attending physician deems the patient a candidate for RRT for at least one of the following reasons:

   1. Presence of oliguria, defined as a urine output of \< 100 mL in the preceding 4 hours
   2. metabolic acidosis (HCO3- \< 15 mmol/L and pH \< 7.25)
   3. refractory hyperkalemia (K \> 6.0 mmol/L)
   4. azotemia (BUN \> 50 mmol/L)
   5. suspected uremic organ involvement (pericarditis, encephalopathy, neuropathy or myopathy)

Exclusion Criteria:

1. renal replacement therapy within the previous 2 months
2. presence of renal obstruction
3. receipt of a kidney transplant in the previous year
4. diagnosis of rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
5. indication for intermittent hemodialysis, specifically severe hyperkalemia, dialyzable drug or toxin
6. terminal illness with associated life expectancy less than 2 months
7. patients who are moribund
8. prior enrollment in this study
9. enrollment in a competing ICU interventional study
10. no CRRT machine available
11. acute renal replacement ongoing for \> 36 hours
B: Inclusion Criteria:

* Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis
* Plan for renal replacement therapy by clinical team
* Receiving care in a critical care unit
* One non-renal organ failure or sepsis
* Age 18 or older
* Patient or surrogate provides informed consent

Exclusion Criteria:

* Baseline serum creatinine \> 2 mg/dL (177 mol/L) in males, \> 1.5 mg/dL (133 mol/L) in females
* Acute renal failure clinically believed to be due to an etiology other than acute tubular necrosis
* More than 72 hours since meeting both of the following conditions:

  1. Fulfillment of the definition of ARF; and
  2. BUN \> 100 mg/dL (36 mmol/L)
* More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy
* Prior kidney transplant
* Pregnancy
* Prisoner
* Weight \> 128.5 kg
* Non-candidacy for renal replacement therapy
* Moribund state
* Patient not expected to survive 28 days because of underlying terminal chronic medical condition
* Comfort-measures-only status
* Participation in a concurrent interventional study
* Patient/surrogate refusal
* Physician refusal
C: Inclusion Criteria:

* Patients 18 years or older
* Written informed consent
* No pre-existing dialysis dependency

Exclusion Criteria:

* Minors / children
* No consent
* Severe electrolyte disturbances which necessitates special dialysis therapy
D: Inclusion Criteria (all of these need to be present):

1. Age ≥ 18 years
2. Admission to an intensive care unit
3. Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or

   ≥ 130 µmol/L (men))
4. Evidence of severe AKI defined by at least 2 of the following 3 criteria:

   i-A 2-fold increase in serum creatinine during hospitalization or from a known pre-hospitalization baseline ii-Oliguria as defined by total urine output \< 6 mL/kg over the preceding 12 hours iii-Whole blood Neutrophil Gelatinase-Associated Lipocalin (NGAL) ≥ 400ng/mL
5. Likelihood that an absolute indication for RRT will not arise in the subsequent 24 hours based on the most recent bloodwork for the following parameters: i- Serum potassium ≤ 5.5 mmol/L and ii- Serum bicarbonate ≥ 15 mmol/L
6. Central venous pressure ≥ 8 mmHg

Exclusion Criteria (the presence of one of these would disqualify eligibility):

1. Lack of commitment to ongoing life support
2. Presence of a drug overdose that necessitates initiation of RRT
3. Any RRT within the previous 2 months
4. Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
5. Advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 30 mL/min/1.73 m2, based on pre-hospitalization blood work
6. Kidney transplant within the past 365 days
7. At the time of screening, doubling of serum creatinine has been present for \> 48 hours
8. Clinician(s) caring for patient believe(s) that immediate dialysis is absolutely mandated
9. Clinician(s) caring for patient believe(s) that deferral of dialysis initiation is mandated
10. Patient or substitute decision maker can not provide consent within 12 hours of study eligibility

Answer: B