None listed
Conditions
Brief summary
The hypothesis that this trial will test is that the citrate/calcium approach for regional anticoagulation is more effective than the heparin/protamine method at maintaining functional filter life in patients receiving continuous renal replacement therapy (CRRT). CRRT is the form of dialysis that is used in the intensive care unit for critically ill patients. Blood is removed from the patients body and circulated through a membrane before being returned. This circuit outside the body causes the blood to start clotting unless a drug is used to prevent this happening. We will compare two different methods of preventing this clotting to see which one can prevent the blood clotting for the longer time. Prevention of blood clotting in the circuit is desirable because of the interruptions in treatment that this causes.
Interventions
Regional citrate anticoagulation of a continuous renal replacement therapy circuit. Fluids containing citrate are infused into extracorporeal venous blood pre-blood pump to achieve a final concentration of approximately 3mmol/L (this is the anticoagulant dose). This causes hypocalcaemia and anticoagulation. The patient is prevented from becoming hypocalcaemic by the use of a systemic calcium infusion (hence the anticoagulation is only in one region of the circuit). The citrate is infused continu
Regional citrate anticoagulation of a continuous renal replacement therapy circuit. Fluids containing citrate are infused into extracorporeal venous blood pre-blood pump to achieve a final concentration of approximately 3mmol/L (this is the anticoagulant dose). This causes hypocalcaemia and anticoagulation. The patient is prevented from becoming hypocalcaemic by the use of a systemic calcium infusion (hence the anticoagulation is only in one region of the circuit). The citrate is infused continuously during treatment with renal replacement therapy and lasts for the duration of the renal replacement therapy.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All must apply: a) the treating clinician believes that the patient requires CRRT for acute renal failure, b) the clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with citrate/calcium or heparin/protamine, d) informed consent has been obtained, or will be sought within 48h in those centres where delayed consent has been approved, e) the patient fulfils ONE of the following clinical criteria for initiating CRRT: (i) oliguria (urine output < 100ml/6hr) that has been unresponsive to fluid resuscitation measures. (ii) hyperkalemia ([K+] > 6.5 mmol/L), (iii) severe acidemia (pH < 7.2), (iv) urea > 25 mmol/L., (v) Creatinine >300 micromol/L, (vi) clinically significant organ oedema in the setting of acute renal failure (ARF) (eg: lung).
Exclusion criteria
Any one may apply: a) expected short stay ICU (< 24hours), b) Age < 18 years, c) Acute or chronic liver failure, d) suspected ischaemic hepatitis, e) known allergy to protamine or heparin, f) suspected or confirmed heparin-induced thrombocytopenia, g) there is a strong likelihood that the study treatment would not be continued in accordance with the study protocol
Outcome results
None listed