Bleeding, Continuous Renal Replacement Therapy, Hyperlactatemia
Conditions
Brief summary
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Detailed description
For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Interventions
PROCEDURERegional citrate anticoagulation CRRT
Regional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
PROCEDURENo-anticoagulation CRRT
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥16 years * Hyperlactatemia (Lactic acid or serum lactate level \> 2 mmol/L) * Required CRRT * Increased bleeding risk: PLT \< 40 x 109, aPTT \> 60 s, INR \> 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.
Exclusion criteria
* Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia. * Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours. * Critical patients with lactic acid ≥15mmol\\L (with a mortality of 100%) were excluded * Patients with APTT \> 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours) * Patients who are pregnant or during lactation * Severe liver failure: child-pugh score \>10 (chronic severe liver failure), MELD score \> 30 (acute severe liver failure), total bilirubin \>51 mol/L * Patients with internal fistula were treated with CRRT * Unable to cooperate with treatment due to mental problems (such as depression and mental illness) * CRRT with arteriovenous fistula, or the prescribed treatment time \< 12 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filter failure | 72 hours | TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum AST level | Every 24 hours up to 72 hours | AST |
| Serum total bilirubin level | Every 24 hours up to 72 hours | Total bilirubin |
| Serum citrate concentration | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours | Citrate concentration |
| Serum lactate level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours | Serum lactate level |
| citrate accumulation | 72 hours | Metabolic acidosis with an increased anion gap, decreasing ionized calcium, elevated total calcium and the calcium ratio (totCa/ionCa) \> 2.5 were considered as citrate accumulation. |
| Hypocalcemia | 72 hours | Ionized Ca2+ \< 1.0 |
| Serum Total Ca2+/ion Ca2+ level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours | Serum Total Ca2+/ion Ca2+ level |
| Alkalosis | 72 hours | Blood pH \> 7.45 |
| Bleeding | 72 hours | Bleeding episode during the CRRT |
| APTT | Every 24 hours up to 72 hours | activated partial thromboplastin time |
| PT | Every 24 hours up to 72 hours | Prothrombin time |
| INR | Every 24 hours up to 72 hours | International normalized ratio |
| Mortality | Up to 3 months | In-hospital mortality |
| Acidosis | 72 hours | Blood pH \< 7.35 |
Countries
China
Contacts
Primary ContactMing Bai, MD
Outcome results
None listed