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

Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment: a Multicenter Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatic Failure; CKD 5D, Hemodialysis; AKI - Acute Kidney Injury
• Intervention / Treatment: Other: Two-stage calcium supplementation in RCA-CRRT; Other: Commercial RCA-CRRT module

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Commercial RCA-CRRT module; The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
Experimental: Two-stage	Other: Two-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2026
• Primary Completion (Estimated): February 14, 2028
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Renal Replacement Therapy (CRRT); Regional Citrate Anticoagulation (RCA)
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Liver Diseases; Renal Insufficiency; Hepatic Insufficiency; Acute Kidney Injury; Liver Failure
• Other Study ID Numbers: RCA-CRRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No