Clinical trial NCT06983509: Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy
Official title: Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR): a Multicenter, Prospective Real-world
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Insufficiency
Keywords: Continuous renal replacement therapy
Hemofiltration replacement solutions
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Filter Lifespan - Duration
timeFrame: 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
measure: Filter Lifespan - Replacement or Discontinuation
timeFrame: 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
measure: Electrolyte and Acid-Base Indicators - Calcium
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - Potassium
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - Sodium
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - Phosphate
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - Magnesium
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - Bicarbonate
timeFrame: 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.
measure: Electrolyte and Acid-Base Indicators - pH
timeFrame: 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.
measure: User experience of the pre-mixed solutions
timeFrame: At the end of the study, i.e., Day 30 post treatment
measure: Severe bleeding events
timeFrame: From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment
measure: Citrate accumulation
timeFrame: From initiation of the 1st CRRT with sponsored solutions until Day 7 post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: The First People's Hospital of Guangzhou
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Shangai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: ZhongShan Hospital Fudan University
city: Wuhan
country: China
facility: Zhongnan Hospital, Wuhan University
Study officials:
References: