NCT04315623

RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Continuous Renal Replacement Therapy
• Hyperlactatemia
• Bleeding

Interventions

Type	Name	Description
PROCEDURE	Regional 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.
PROCEDURE	No-anticoagulation CRRT	Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.

Timeline

• Start date: 2020-03-30
• Primary completion: 2022-03-01
• Completion: 2022-03-03
• First posted: 2020-03-19
• Last updated: 2020-03-19

Locations

1 site across 1 country: China