Renal InsufficiencyPrioRNCT06983509
Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy
An observational study of Renal Insufficiency, run by Vantive Health LLC at 10 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Regiocit, Biphozyl and Prismasol 2
- Type of treatment
- Injection or infusion
- How many people
- 228 participants
- Where
- 10 sitesChina
- Study dates
- 23 Oct 2024to 11 Sep 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Critically ill adult patients who require CRRT with one of the following pre-mixed solutions: Regiocit, Biphozyl, or Prismasol 2.
Who may be able to join
- 18 ≤ age < 80 years old.
- Patients admitted to the intensive care unit (ICU) and in need of CRRT.
- Patients are willing to receive CRRT with at least one of three pre-mixed solutions:
- Regiocit, Biphozyl, or Prismasol 2.
Who cannot join
- Patients with chronic kidney failure who are receiving maintenance dialysis.
- Patients expected to require the premixed solution for less than 24 hours.
- Patients who are allergic or have contraindications to components of pre-mixed solutions, as determined by the investigators.
- Patients who have participated in other interventional studies within the last 30 days.
- Patients who are pregnant, breastfeeding, or abortus imminence.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Chao-yang Hospital, Capital Medical University
Beijing, 100020
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Xuanwu Hospital Capital Medical University
Beijing, 100053
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
The First People's Hospital of Guangzhou
Guangzhou, 510180
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280
Zhejiang Provincial People's Hospital
Hangzhou, 310014
ZhongShan Hospital Fudan University
Shanghai, 200032
Shanghai East Hospital
Shanghai, 200120
Zhongnan Hospital, Wuhan University
Wuhan, 430071
About this study
Official title: Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR): a Multicenter, Prospective Real-world
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.
Read the detailed description
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.
- Conditions
- Renal Insufficiency
- Being tested
- Regiocit, Biphozyl, Prismasol 2
- Keywords
- Continuous renal replacement therapy, Hemofiltration replacement solutions
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegiocitDrug
Also called Sodium citrate replacement solution
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.
BiphozylDrug
Also called Phosphorus/sodium bicarbonate replacement solution
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.
Prismasol 2Drug
Also called Sodium bicarbonate replacement solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Regiocit; Drug: Biphozyl; Drug: Prismasol 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter Lifespan - Duration
The duration of filter use during the use of pre-mixed solutions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Phosphate
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At the end of the study, i.e., Day 30 post treatment
Severe bleeding events
- The requirement to transfuse 400 mL of whole blood or more than 2U of red blood cell suspension/concentrated red blood cells due to bleeding in a single time.
- Bleeding that requires reoperation
- New-onset intracranial hemorrhage without traumatic events.
Measured: 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)
Measured: From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start23 Oct 2024
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983509
- Sponsor's protocol ID
- BXU605703
- Acronym
- PrioR
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR): a Multicenter, Prospective Real-world
- ClinicalTrials.gov ID
- NCT06983509
- Acronym / sponsor ID
- PrioR / BXU605703
- Conditions
- Renal Insufficiency
- Keywords
- Continuous renal replacement therapy, Hemofiltration replacement solutions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 21 May 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRRT with Regiocit/Prismasol 2/Biphozyl | – | Drug: Regiocit, Drug: Biphozyl, Drug: Prismasol 2Critically 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients who require CRRT with one of the following pre-mixed solutions: Regiocit, Biphozyl, or Prismasol 2.
Key inclusion criteria (4 listed)
- 18 ≤ age < 80 years old.
- Patients admitted to the intensive care unit (ICU) and in need of CRRT.
- Patients are willing to receive CRRT with at least one of three pre-mixed solutions:
- Regiocit, Biphozyl, or Prismasol 2.
Key exclusion criteria (5 listed)
- Patients with chronic kidney failure who are receiving maintenance dialysis.
- Patients expected to require the premixed solution for less than 24 hours.
- Patients who are allergic or have contraindications to components of pre-mixed solutions, as determined by the investigators.
- Patients who have participated in other interventional studies within the last 30 days.
- Patients who are pregnant, breastfeeding, or abortus imminence.
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 |
|---|---|---|
| RegiocitAlso: Sodium citrate replacement solutionRegiocit 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. | Drug | CRRT with Regiocit/Prismasol 2/Biphozyl |
| BiphozylAlso: Phosphorus/sodium bicarbonate replacement solutionBiphozyl 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. | Drug | CRRT with Regiocit/Prismasol 2/Biphozyl |
| Prismasol 2Also: Sodium bicarbonate replacement solutionPrismasol 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. | Drug | CRRT with Regiocit/Prismasol 2/Biphozyl |
Primary outcome
Filter Lifespan - Duration
Time frame: 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
The duration of filter use during the use of pre-mixed solutions
Filter Lifespan - Replacement or Discontinuation
Time frame: 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
The reasons for replacing or discontinuing the filter during the use of pre-mixed solutions
Electrolyte and Acid-Base Indicators - Calcium
Time frame: 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.
Serum ionized calcium, total calcium and post-filter ionized calcium
Electrolyte and Acid-Base Indicators - Potassium
Time frame: 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.
Potassium
Electrolyte and Acid-Base Indicators - Sodium
Time frame: 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.
Sodium
Electrolyte and Acid-Base Indicators - Phosphate
Time frame: 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.
Phosphate
Electrolyte and Acid-Base Indicators - Magnesium
Time frame: 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.
Magnesium
Electrolyte and Acid-Base Indicators - Bicarbonate
Time frame: 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.
Bicarbonate
Electrolyte and Acid-Base Indicators - pH
Time frame: 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.
Blood pH value
User experience of the pre-mixed solutions
Time frame: At the end of the study, i.e., Day 30 post treatment
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.
Severe bleeding events
Time frame: From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment
1. The requirement to transfuse 400 mL of whole blood or more than 2U of red blood cell suspension/concentrated red blood cells due to bleeding in a single time. 2. Bleeding that requires reoperation 3. New-onset intracranial hemorrhage without traumatic events.
Citrate accumulation
Time frame: From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment
Defined as a total/ionized calcium ratio in serum >2.5, with metabolic acidosis (as determined by the investigator)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, run by Vantive Health LLC at 10 sites in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Filter Lifespan - Duration (time frame: 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). The study lists 12 primary outcomes in all. 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 15 Apr 2026.