An interventional study of Two-stage calcium supplementation in RCA-CRRT and Commercial RCA-CRRT module in AKI - Acute Kidney Injury, CKD 5D, Hemodialysis and Hepatic Failure, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 142 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Two-stage calcium supplementation in RCA-CRRT
Other: Commercial RCA-CRRT module
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.
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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.
Time frame: From 1 hour post-CRRT initiation to the end of CRRT
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →