Acute Kidney Injury, Coagulopathy, Hemorrhage
Conditions
Keywords
Critical illness, Heparin-grafted membrane, Circuit lifespan, Continuous renal replacement therapy, Anticoagulation free, Bleeding risk, Acute kidney injury
Brief summary
The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.
Detailed description
Aims and objectives: We aim to compare the performance and safety of heparin-grafted AN69 membrane (oXiris, Gambro) with the conventional AN69 membrane (M150, Gambro) without systemic anticoagulation during continuous renal replacement therapy (CRRT), in critically ill patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.
Interventions
DEVICEoXiris as first filter
2 arms - each start off CRRT with either oXiris or M150 as first hemofilter, and then do cross-over to either hemofilters in a sequential manner when the former clots
DEVICEM150 as first filter
start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized initiation with oXiris versus M150 (conventional filter), with cross-over for subsequent circuits.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (age 21 and above) who are admitted to ICUs or CCU and requiring CRRT for acute kidney injury or ESRD Patients who has moderate bleeding risk (see below definitions) Patients with NO systemic or regional circuit anticoagulation Informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons Anticipated need for prolonged CRRT \> 3 days (Moderate bleeding risk criteria:) Moderate bleeding risk is defined by any of the following: 1. Platelet count \< 100 x 109 mm3 (but \> 50) 2. INR \> 1.5 (but \< 2.5) 3. APTT \> 50 seconds (but \< 75) 4. Post-surgery for \< 48 hours 5. Post-invasive procedures (eg. Pericardiocentasis) \< 24 hrs 6. Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) \< 24 hours 7. Recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted)
Exclusion criteria
Patients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) Patients who are known to have heparin-induced thrombocytopenia or allergic to heparin Patients with other medical conditions for which heparin is contraindicated. Patients who require systemic anticoagulation for medical indications (We will accept patients who are on prophylactic doses of anticoagulation for DVT prophylaxis) Patients who are pregnant Patients/legally accepted surrogate who decline to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150) | usually 10 - 30 hours from commencement of circuit | Circuit lifespan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-circuit INR/APTT, and post-circuit INR/APTT 2 hours after termination. (We will be using the 2 hour post-circuit APTT result of the preceding dialyzer, as the pre-circuit APTT for the subsequent dialyzer. | Usually after 10-30 hours when dialyzer clots | effect on coagulation status |
| Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine protein layering and solute clearance. | Usually 4 hours into circuit commencement | effect on clearance |
| Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol. | over 10-30 hours of circuit running | effect on circuit pressures |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total inotropic score, which is defined as total quantities of Dopamine + Dobutamine + 100 (Noradrenaline) + 100 (Adrenaline) in mcg/kg/min; pre- and post- use of the circuit. | usually after 10-30 hours of circuit lifespan | effect on hemodynamics |
| Urine output over the 6 hours preceding the commencement of first circuit, and 6 hours after termination of the first circuit. | Usually after 10-30 hours of circuit lifespan | effect on oliguria |
Countries
Singapore
Outcome results
None listed