Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study: A Pilot Randomized Controlled Trial of Convective Versus Diffusive Clearance
Brief Summary: Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly. However, minimal evidence exists to guide the prescription of optimal renal replacement therapy (RRT). An important area of uncertainty surrounds the relative effects of convective versus diffusive modes of clearance. Although both clearance modes provide similar degrees of small molecule clearance, convective modes permit the enhanced clearance of larger-sized molecules which may mediate kidney and systemic toxicity in the setting of AKI.

Continuous renal replacement therapies (CRRTs) are frequently applied in critically ill patients with AKI. Convective clearance, as applied through continuous venovenous hemofiltration (CVVH) and diffusive clearance, as applied through continuous venovenous hemodialysis (CVVHD), may be readily compared in the context of patients receiving CRRT.

The purpose of this study is to examine the feasibility of conducting a larger study that will determine whether convective clearance (hemofiltration) confers improved outcomes as compared to diffusive clearance (hemodialysis) in patients with AKI.


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:

1. Patients admitted to intensive care unit (ICU) of age \>18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started.
2. Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
3. Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.

Exclusion Criteria:

1. Infected with Hepatitis B or C or HIV.
2. Dependence on dialysis treatment before the actual ICU episode.
C: Inclusion Criteria:

1. Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)

   Or

   Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
2. At least one of the following conditions

   * Sepsis or septic shock
   * Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
   * Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 \< 300 mmHg and/or fluid balance \> 10% of body weight)
3. 18-90 years old
4. Intention to provide full intensive care treatment for at least 3 days
5. Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation

Exclusion Criteria:

1. Patients with increased bleeding risk (e.g. an active bleeding from ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, injuries (intracranial hemorrhage, aneurysm of brain arteries) of or surgical procedures on the central nervous system if a heparinization with a target aPTT 45-60 s is not allowed by the treating neurologist or neurosurgeon, severe retinopathies, bleeding into the vitreum, ophthalmic surgical procedures)) or injuries, active tuberculosis; infective endocarditis)
2. Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
3. Dialysis-dependent chronic kidney insufficiency
4. Need of therapeutic systemic anticoagulation
5. Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia
6. AKI caused by permanent occlusion or surgical lesion of the renal artery
7. AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction
8. Do-not-resuscitate order
9. Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
10. Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
11. Kidney transplant within the last 12 months
12. Pregnancy and nursing period
13. Abortus imminens
14. No hemofiltration machine free for use at the moment of inclusion
15. Participation in another clinical intervention trial in the last 3 months
16. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
17. Persons held in an institution by legal or official order
D: 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

Answer: A