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Table 3 Key inclusion and exclusion criteria of the study

From: Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial

Inclusion criteria

1. Patient must be more than 18 years old.

2. Acute decompensated HF within 24 h of hospital admission.

3. Fluid overload, defined as edema of the lower extremities and at least 1 of the following: 1) elevated jugular venous pressure > 10 cm H2O, 2) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea, 3) pulmonary edema or pleural effusion on chest X-ray, 4) enlarged liver or ascites, 5) pulmonary wedge or left ventricular end diastolic pressure ≥ 20 mmHg, or 6) rapid increase of body weight ≥ 2 kg.

4. NYHA classification III-IV.

5. Patient is informed and has signed informed consent. Patient is willing to attend an outpatient follow-up.

Exclusion criteria

1. Acute coronary syndrome.

2. Severe mitral or aortic stenosis.

3. Severe renal insufficiency (serum creatinine ≥3.0 mg/dl or eGFR ≤ 30 mL/min).

4. Systolic blood pressure ≤ 90 mmHg or depending on high dose of vasoactive drug to maintain systolic blood pressure ≥ 90 mmHg.

5. Hematocrit > 45%.

6. Unattainable venous access.

7. Comorbidities expected to prolong hospitalization.

8. Contraindications to anticoagulation.

9. Serious bleeding in the last 6 months (this includes, but is not limited to, prior intracranial hemorrhage, active peptic ulcer disease, active internal bleeding, bleeding at a noncompressible site).

10. Hematuria within 30 days before randomization.

11. Patients at high risk of bleeding (this includes, but is not limited to, clinically significant thrombocytopenia or anemia, platelet count < 90,000/μL at screening or pre-randomization, anemia of unknown cause with a hemoglobin level < 10 g/dL at screening or pre-randomization, coagulation disorders, recent stroke within past 30 days, documented hemorrhagic tendencies, or blood dyscrasias).

12. Uncontrolled hypertension (> 180/110 mmHg).

13. Severe infection.

14. Use of iodinated radiocontrast material.

15. Participation in another controlled clinical trial, either within the past 2 months or still ongoing.

16. Women who are pregnant, breast-feeding, or of child-bearing potential.

17. Patient who is mentally ill.