AKI - Acute Kidney Injury, CKD 5D, Hemodialysis, Hepatic Failure
Conditions
Keywords
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Brief summary
The purpose of this study is to compare the efficacy and safety of an individualized two-stage calcium supplementation method versus a conventional commercial RCA-CRRT module in RCA-CRRT for patients with citrate metabolism disorders.
Interventions
OTHERTwo-stage calcium supplementation in RCA-CRRT
The two-stage calcium supplementation refers to: the first stage after the initiation of CRRT, the amount of calcium supplementation includes the calcium clearance from the extracorporeal circuit and the accumulated calcium citrate in the body; when the blood citrate concentration reaches a steady state, the second stage begins, at which point the accumulated calcium is stable and only the calcium clearance from the extracorporeal circuit needs to be supplemented.
OTHERCommercial RCA-CRRT module
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
A. Aged 18 to 80 years, inclusive, male or female; B. Diagnosed with acute kidney injury or chronic kidney disease stage 5, and assessed by a physician as requiring continuous renal replacement therapy (CRRT); C. Citrate metabolism disorder, including liver failure (acute liver failure, acute-on-chronic liver failure, or decompensated cirrhosis), and/or microcirculation disorder (mean arterial pressure \<65 mmHg requiring vasopressor therapy and lactate ≥2 mmol/L); D. The investigator determines that the patient can have a stable vascular access established (the access must be capable of providing a constant and effective blood flow rate \>150 ml/min); E. The study participant (subject) and their legal guardian are able to understand the study purpose and provide written informed consent.
Exclusion criteria
A. Received regional citrate anticoagulation therapy within the previous 72 hours; B. Expected to require additional non-protocol calcium supplementation during CRRT due to disease-related needs; C. Requiring arterial-venous reversal of the extracorporeal circuit during CRRT due to poor flow; D. Requiring concurrent peritoneal dialysis during the trial period; E. Participated in or is currently participating in another clinical trial within 1 month prior to the date of signing the informed consent form; F. Expected survival time less than 72 hours; G. Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention rate of iCa | From 1 hour post-CRRT initiation to the end of CRRT | During the CRRT iCa is measured at pre-set time points. If the iCa concentration is either \<0.95 or \>1.35 mmol/L in the body, or \<0.25 or \>0.4 mmol/L in the extracorporeal circuit, it is defined as "iCa requiring intervention". If both intracorporeal and extracorporeal iCa require intervention at the same time point, it is counted as two interventions. Finally, the intervention rate of iCa is calculated. |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of metabolic acidosis and metabolic alkalosis | From 1 hour post-CRRT initiation to the end of CRRT |
| The incidence of hypernatremia | From 1 hour post-CRRT initiation to the end of CRRT |
| The incidence of clinically meaningful citrate accumulation | From 1 hour post-CRRT initiation to the end of CRRT |
| The filter failure rate and the causes of filter failure within 72 hours | The first 72 hours of CRRT |
| The differences and proportional distributions of in vivo and in vitro iCa values at each time point between the two groups | From 1 hour post-CRRT initiation to the end of CRRT |
| The incidence of bleeding events, the bleeding-related blood transfusions, and the total volume of transfused blood | From the initiation to the end of CRRT |
| The incidence of hypocalcemia and hypercalcemia | From 1 hour post-CRRT initiation to the end of CRRT |
| The incidence of arrhythmias and neurological symptoms caused by abnormal iCa | From 1 hour post-CRRT initiation to the end of CRRT |
Outcome results
None listed