Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment

NCT07579663 | Not Yet Recruiting DMC

• 1 other identifier: RCA-CRRT
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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.

Conditions

AKI - Acute Kidney Injury; CKD 5D, Hemodialysis; Hepatic Failure

Keywords

Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT)

Outcome Measures

Primary Outcomes (1)

• Intervention rate of iCa

  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.

  From 1 hour post-CRRT initiation to the end of CRRT

Secondary Outcomes (8)

• 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 arrhythmias and neurological symptoms caused by abnormal iCa

  From 1 hour post-CRRT initiation to the end of CRRT

• The incidence of hypocalcemia and hypercalcemia

  From 1 hour post-CRRT initiation to the end of CRRT

Study Arms (2)

Two-stage

EXPERIMENTAL

Other: Two-stage calcium supplementation in RCA-CRRT

Control

ACTIVE COMPARATOR

Other: Commercial RCA-CRRT module

Interventions

Two-stage calcium supplementation in RCA-CRRT OTHER

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.

Two-stage

Commercial RCA-CRRT module OTHER

The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Acute Kidney Injury; Liver Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): February 14, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04