Investigating different anticoagulants for renal replacement therapy

Phase 1

• Conditions: Critically ill patients with acute kidney injury; MedDRA version: 20.0Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004854-33-DE
• Lead Sponsor: niversity Hospital Muenster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1450

Inclusion Criteria

1.Critically ill patients with clinical indication for CRRT
oUrea serum levels > 150 mg/dl or
oPotassium serum levels > 6 mmol/l or
oMagnesium serum levels > 4 mmol/l or
oBlood pH = 7.15 or
oUrine production < 200 ml/12 h or anuria or
oOrgan edema in the presence of AKI resistant to diuretic treatment
Or
Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
2.At least one of the following conditions
oSepsis or septic shock
oUse of catecholamines (norepinephrine or epinephrine = 0.1 µg/kg/min or norepinephrine = 0.05 µg/kg/min + dobutamine or norepinephrine = 0.05 µg/kg/min + vasopressin or norepinephrine = 0.05µg/kg/min + epinephrine =0.05µg/kg/min)
oRefractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
3.18-90 years old and
4.Intention to provide full intensive care treatment for at least 3 days and
5.Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 580
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 870

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 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 procdures or injuries, active tuberculosis, infective endocarditis)
2. Diseases or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
3. Dialysis-dependent chronic kidney insufficiency
4. Need of therapeutic anticoagulation (PTT > 60s, antiXa > 0.6 IE/ml, INR > 2)
5. Allergic reaction to one of the anticoagulantia, or ingredients, Heparin-induced thrombocytopenia
6. AKI caused by permanent occlusion or surgical lesion of both renal arteries
7. AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis
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 ordner

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified