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This is a multicenter, prospective, registry study. By collecting relevant demographic information and clinical data of patients receiving continuous renal replacement therapy (CRRT) with pre-mixed solutions, the clinical applicability of pre-mixed solutions will be evaluated in critically ill patients in real-world clinical settings.
This study will be carried out in approximately 10 study sites in China. Patient data will be collected to evaluate the clinical applicability of pre-mixed solutions.
Treatment observation period: From initiation of the first CRRT with sponsored pre-mixed solutions to cessation of the pre-mixed solutions. The duration of this period can be up to 10 days.
Follow-up period: from the cessation of sponsored pre-mixed solutions to Day 30 after starting treatment with the pre-mix solutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRRT with Regiocit/Prismasol 2/Biphozyl | Critically ill adult patients receiving CRRT with at least one of the three pre-mixed solutions (Regiocit, Prismasol 2, or Biphozyl). The mode of therapy, solute formulations, flow rates, fluid removal rate, and length of therapy is selected by the physician responsible for managing treatment, depending on the clinical condition of the patient, as well as the patient's fluid, electrolyte, acid-base, and glucose balance. An initial CRRT dose of 30 mL/kg/h is advised to achieve the recommended effluent volume of 20 to 25 mL/kg/h. Patients weighing more than 100 kg may not exceed a CRRT dose of 4 L/h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regiocit | Drug | Regiocit can be used as a replacement fluid for CRRT with RCA. It will be used in pre-dilution mode only. At least 200 mL of post-replacement solution is recommended to minimize clotting in the de-aeration chamber. A replacement/dialysate solution with 22 to 26 mEq/L bicarbonate buffer is advised as the first choice. A higher concentration of bicarbonate may be required in severe cases of acidosis. The use of a non-calcium-containing dialysate or replacement fluid is advised. The rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Regiocit will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 to 4 mmol/L. A BFR between 100 to 180 mL/min will be advised; a lower BFR can minimize patient citrate exposure, particularly in patients with lower body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Filter Lifespan - Duration | The duration of filter use during the use of pre-mixed solutions | From initiation of 1st CRRT with sponsored solutions until mandatory replacement at 72 hours, death, access problems, filter or circuit clotting, filter membrane rupture, elective stopping of the filter, or achievement of treatment goals, whichever first |
| Filter Lifespan - Replacement or Discontinuation | The reasons for replacing or discontinuing the filter during the use of pre-mixed solutions | From initiation of 1st CRRT with sponsored solutions until mandatory replacement at 72 hours, death, access problems, filter or circuit clotting, filter membrane rupture, elective stopping of the filter, or achievement of treatment goals, whichever first |
| Electrolyte and Acid-Base Indicators - Calcium | Serum ionized calcium, total calcium and post-filter ionized calcium | Within 4 hours before the start of CRRT (baseline), 2h ± 1h, 6h ± 2h after the start of CRRT, and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - Potassium | Potassium | Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - Sodium | Sodium | Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - Phosphate |
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Inclusion Criteria:
Regiocit, Biphozyl, or Prismasol 2.
Exclusion Criteria:
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Critically ill adult patients who require CRRT with one of the following pre-mixed solutions: Regiocit, Biphozyl, or Prismasol 2.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-yang Hospital, Capital Medical University | Beijing | 100020 | China | |||
| Beijing Anzhen Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010758 | Phosphorus |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Biphozyl | Drug | Biphozyl is used as a replacement fluid during CRRT. It is injected into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the filter. After the initiation of RRT, Biphozyl is used for late treatment of the acute condition when pH, potassium, and phosphate concentrations return to normal. Biphozyl can also be used if any other buffer is in use or during RCA. The volume and rate of administration of Biphozyl depend on the blood concentration of phosphate and other electrolytes, acid-base balance, body fluid balance, and overall clinical condition of the patient. The volume of replacement fluid given also depends on the expected intensity (dosage) of treatment. |
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| Prismasol 2 | Drug | Prismasol 2 is used as a replacement fluid during CRRT. It is injected into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the filter. The volume and rate of administration of Prismasol 2 depend on the blood concentration of electrolytes, acid-base balance, fluid balance, and overall clinical condition of the patient. The volume of replacement fluid administered also depends on the required intensity (dosage) of the treatment. |
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Phosphate |
| Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - Magnesium | Magnesium | Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - Bicarbonate | Bicarbonate | Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| Electrolyte and Acid-Base Indicators - pH | Blood pH value | Within 4 hours before the start of CRRT (baseline), and daily after 24h of CRRT initiation until the end of use of the pre-mixed solutions during the 1st CRRT session. |
| User experience of the pre-mixed solutions | A questionnaire about the preparation time, ease of operation, and additional workload when using the pre-mixed solutions will be provided to the investigators to collect information on user experience. | At the end of the study, i.e., Day 30 post treatment |
| Severe bleeding events |
| From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment |
| Citrate accumulation | Defined as a total/ionized calcium ratio in serum >2.5, with metabolic acidosis (as determined by the investigator) | From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment |
| Beijing |
| 100029 |
| China |
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
| The First People's Hospital of Guangzhou | Guangzhou | 510180 | China |
| Zhujiang Hospital, Southern Medical University | Guangzhou | 510280 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| ZhongShan Hospital Fudan University | Shanghai | 200032 | China |
| Shanghai East Hospital | Shanghai | 200120 | China |
| Zhongnan Hospital, Wuhan University | Wuhan | 430071 | China |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |