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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Two-stage calcium supplementation in RCA-CRRT

    Other intervention

    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 module

    Other intervention

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

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Two-stageExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

The filter failure rate and the causes of filter failure within 72 hours

Time frame
The first 72 hours of CRRT
2

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
3

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
4

The incidence of arrhythmias and neurological symptoms caused by abnormal iCa

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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