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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Xijing Hospital of Nephrology
Xi'an, Shaanxi, China
Filter failure
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
Time frame: 72 hours
Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ion Ca2+ level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum AST level
AST
Time frame: Every 24 hours up to 72 hours
Serum total bilirubin level
Total bilirubin
Time frame: Every 24 hours up to 72 hours
Serum citrate concentration
Citrate concentration
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum lactate level
Serum lactate level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
citrate accumulation
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.
Time frame: 72 hours
Hypocalcemia
Ionized Ca2+ \< 1.0
Time frame: 72 hours
Acidosis
Blood pH \< 7.35
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Time frame: 72 hours
Alkalosis
Blood pH \> 7.45
Time frame: 72 hours
Bleeding
Bleeding episode during the CRRT
Time frame: 72 hours
APTT
activated partial thromboplastin time
Time frame: Every 24 hours up to 72 hours
PT
Prothrombin time
Time frame: Every 24 hours up to 72 hours
INR
International normalized ratio
Time frame: Every 24 hours up to 72 hours
Mortality
In-hospital mortality
Time frame: Up to 3 months