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:

* Age greater than 18 years
* Renal failure, electrolyte disturbance, or volume overload requiring continuous venovenous hemodialysis (CVVHD) as determined by the Nephrology consult service

Exclusion Criteria:

* Age less than 18 years
* Active bleeding
* Coagulopathy as defined by baseline INR \> 1.8, aPTT \> 45 seconds, or platelet count \< 50 thousand/μL
* Active administration of systemic anticoagulation (such as warfarin, therapeutic unfractionated heparin, or therapeutic enoxaparin)
* Contraindication to heparin (allergy, thrombocytopenia with platelet count \< 50, known or suspected heparin induced thrombocytopenia \[HIT\])
* Contraindication to systemic anticoagulation (recent surgical or other invasive procedure, significant bleeding disorder, concern for intracranial bleeding, or other contraindication as determined by treating physician)
* Administration of drotrecogin (Xigris™)
* Anticipated surgical or other invasive procedure that would necessitate withdrawal of anticoagulation within 72 hours
* Expected termination of continuous renal replacement therapy (CRRT) or death in \< 24 hours
* The need for more than 500 cc an hour of IV fluids delivered proximal to the filter for the purpose of performing continuous venovenous hemofiltration (CVVH) or continuous venovenous hemodiafiltration (CVVHDF)
B: Inclusion Criteria:

* Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria)
* Patients (males or females) \> 18 yrs old
* Consent form signed (or in emergency investigator's statement form)

Exclusion Criteria:

* Patients with active bleeding disorders
* Patients with past history of heparin-induced thrombocytopenia (HIT)
* Patients with very severe liver disease ( patients awaiting liver transplant or factor V \< 20% or MELD score \> 25)
* Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion)
* Enrollment in another concurrent therapeutic trial
C: Inclusion Criteria:

1. Injury stage of RIFLE criteria or more: \> 2-fold increase in the serum creatinine or urine output \< 0.5 mL/kg/hr for 12 hours
2. Patients with any dialysis treatment before admission to the ICU or patients with end-stage renal failure and receiving dialysis
3. Informed consent has been obtained.

Exclusion Criteria:

1. patient age \< 20 years or \> 85 years
2. life expectancy less than 3 months (ex. terminal stage of malignancy)
3. Child-Pugh class C liver cirrhosis
4. pregnancy or lactation
5. history of anticoagulation prior to the randomization
6. bleeding tendency (platelet count \< 50,000/ul, INR \> 2.5, PTT \> 65, or fibrinogen \< 1.00 g/L)
7. history of hemorrhagic disease (ex. GI bleeding, cerebral hemorrhage, pulmonary hemorrhage)
D: 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

Answer: D