CompletedNot Applicable

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

China228 participantsStarted 2024-10-23

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Filter Lifespan - Replacement or Discontinuation

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.

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.

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.

Trial details

NCT IDNCT06983509

SponsorVantive Health LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-11

View on ClinicalTrials.gov More Renal Insufficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Filter Lifespan - Duration

Filter Lifespan - Replacement or Discontinuation

Electrolyte and Acid-Base Indicators - Calcium

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.

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.