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 range18 Years – 80 Years

SexALL

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.

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.

Electrolyte and Acid-Base Indicators - Phosphate

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 range18 Years – 80 Years

SexALL

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.

Electrolyte and Acid-Base Indicators - Phosphate