None listed
Conditions
Brief summary
The trial aims to determine if heparin and citrate anticoagulation in venovenous haemofitration provide equivalent circuit lifespan in paediatrics. It also aims to determine if additional albumin priming effects circuit lifespan.
Interventions
The randomised cross over trial will aim to determine if additional priming of a haemofilter circuit with 5 u/ml heparinised 4% albumin increases circuit life (compared to only 5 u/ml heparinised saline). This additional priming will be performed before the circuit is connected to the patient.
The study will also determine if there is a difference between regional citrate and global heparinised anticoagulation on circuit life. The dose of citrate (in the form of ADC-A) will be titrated with a
The randomised cross over trial will aim to determine if additional priming of a haemofilter circuit with 5 u/ml heparinised 4% albumin increases circuit life (compared to only 5 u/ml heparinised saline). This additional priming will be performed before the circuit is connected to the patient. The study will also determine if there is a difference between regional citrate and global heparinised anticoagulation on circuit life. The dose of citrate (in the form of ADC-A) will be titrated with a calcium chloride infusion to maintain circuit calcium’s of less than 0.3 mmol/L and a patient calcium of 1.0-1.3 mmol/L. Upon recruitment all participants will be randomly assigned to one of 8 sequences of varying anticoagulation and priming methods as recommended for a four period crossover design with 2 factorial treatments. Their first 4 circuits will consist of two heparin and two citrate circuits, one of each will be primed with heparinised saline and the other with an additional heparinised albumin prime, with the order of the treatments determined by their pre-assigned randomised sequence. As hemofiltration is necessary to maintain these patients there will be no intentional "wash out" period as with holding treatment may be detrimental to the patient. Each circuit will run until TMP (Transmembrane Pressure) reaches 280mmHg, treatment needs to be interrupted for longer than two hours or a significant adverse event occured. The participant will be in the trial for a maximum of eight circuits.
Sponsors
The Royal Childrens' Hospital Mebourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 15 Years
Healthy volunteers
No
Inclusion criteria
Any patient requiring Continuous Veno-venus Haemofiltration (CVVH) in the unit will be eligible for the trial. Parental consent will be obtained before the patient is recruited.
Exclusion criteria
Patients with liver failure defined for the purpose of this trial as INR (international normalized ratio) >3 despite clotting factor replacement (these patients often have the problems of metabolizing heparin and citrate and more severe coagulopathy) or known sensitivity to heparin (i.e. heparin-induced thrombocytopenia) will be excluded from the trial. Patients with significant risk of bleeding (those with intra cranial, cerebral or pulmonary haemorrhage or stroke) will also be excluded, however, coagulopathic or thrombocytopenic patients without significant bleeding will be included. If parental consent cannot be obtained or is not given the child will not participate in the trial.
Outcome results
None listed