AKI - Acute Kidney InjuryPRECISENCT07579663
Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment
A study testing Two-stage calcium supplementation in RCA-CRRT and Commercial RCA-CRRT module in people with AKI - Acute Kidney Injury and CKD 5D, Hemodialysis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- AKI - Acute Kidney Injury, CKD 5D, Hemodialysis, Hepatic Failure
- What is being tested?
- Two-stage calcium supplementation in RCA-CRRT and Commercial RCA-CRRT module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 14 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Being tested
- Two-stage calcium supplementation in RCA-CRRT, Commercial RCA-CRRT module
- Keywords
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
- Medical subject headings
- Acute Kidney Injury, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-stage calcium supplementation in RCA-CRRTOther
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.
Commercial RCA-CRRT moduleOther
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
| Study group | Role | What they receive |
|---|---|---|
| Two-stage | Experimental | Not described Receives: Other: Two-stage calcium supplementation in RCA-CRRT |
| Control | Active comparator | Not described Receives: Other: Commercial RCA-CRRT module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: From the initiation to the end of CRRT
The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
Measured: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of hypocalcemia and hypercalcemia
Measured: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of metabolic acidosis and metabolic alkalosis
Measured: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of hypernatremia
Measured: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of clinically meaningful citrate accumulation
Measured: From 1 hour post-CRRT initiation to the end of CRRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 May 2026 (estimated)
- Primary completion14 Feb 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579663
- Sponsor's protocol ID
- RCA-CRRT
- Acronym
- PRECISE
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment: a Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07579663
- Acronym / sponsor ID
- PRECISE / RCA-CRRT
- Keywords
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 14 Feb 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-stage | Experimental | Other: Two-stage calcium supplementation in RCA-CRRT |
| Control | Active comparator | Other: Commercial RCA-CRRT module |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-stage calcium supplementation in RCA-CRRTThe 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. | Other | Two-stage |
| Commercial RCA-CRRT moduleThe recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care. | Other | Control |
Primary outcome
Intervention rate of iCa
Time frame: 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.
8 secondary outcomes
The filter failure rate and the causes of filter failure within 72 hours
Time frame: 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
Time frame: 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
Time frame: From the initiation to the end of CRRT
The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of hypocalcemia and hypercalcemia
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of metabolic acidosis and metabolic alkalosis
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of hypernatremia
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
The incidence of clinically meaningful citrate accumulation
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Two-stage calcium supplementation in RCA-CRRT and Commercial RCA-CRRT module in people with AKI - Acute Kidney Injury and CKD 5D, Hemodialysis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention rate of iCa (time frame: From 1 hour post-CRRT initiation to the end of CRRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.