Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy

NCT06983509 | Completed

• 1 other identifier: BXU605703
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 10

Brief 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 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.

Conditions

Renal Insufficiency

Keywords

Continuous renal replacement therapy; Hemofiltration replacement solutions

Outcome Measures

Primary Outcomes (12)

• 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

  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

  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.

  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

Study Arms (1)

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.

Drug: Regiocit; Drug: Biphozyl; Drug: Prismasol 2

Interventions

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.

Also known as: Sodium citrate replacement solution

CRRT with Regiocit/Prismasol 2/Biphozyl

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.

Also known as: Phosphorus/sodium bicarbonate replacement solution

CRRT with Regiocit/Prismasol 2/Biphozyl

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.

Also known as: Sodium bicarbonate replacement solution

CRRT with Regiocit/Prismasol 2/Biphozyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients who require CRRT with one of the following pre-mixed solutions: Regiocit, Biphozyl, or Prismasol 2.

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead

Study Sites (10)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, 100020, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The First People's Hospital of Guangzhou

Guangzhou, 510180, China

Location

Zhujiang Hospital, Southern Medical University

Guangzhou, 510280, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 310014, China

Location

ZhongShan Hospital Fudan University

Shanghai, 200032, China

Location

Shanghai East Hospital

Shanghai, 200120, China

Location

Zhongnan Hospital, Wuhan University

Wuhan, 430071, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Phosphorus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 21, 2025
• Study Start: October 23, 2024
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (10)