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Renal Replacement Solution

Prismocitrate 18 for Continuous Renal Replacement Therapy

Q: In how many diverse venues is this experimental examination currently being conducted?

Currently, this research is ongoing at 8 different medical facilities including those in Newark, Pittsburgh, and Chattanooga. It is advisable to choose a site closest to you to reduce travel obligations should you decide to take part.

Q: Has Prismocitrate 18 received official approval from the FDA?

Our team at Power has assigned a safety rating of 3 to Prismocitrate 18 based on the Phase 3 trial stage, indicating that there is evidence supporting both its effectiveness and safety from several data collection rounds.

Q: Is the enrollment for participants in this study currently ongoing?

According to clinicaltrials.gov, this investigation is actively enrolling volunteers. It was initially listed on 4/1/2024 and last modified on 4/13/2024.

Phase 3

Recruiting

Research Sponsored by Baxter Healthcare Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (<=6 hours prior to day 1 initiation of crrt); day 1 (1 hour after initiation of crrt, 1 hour after any prismocitrate dose change until stable) and every 6 hours (i.e., 6h, 12h, 18h, 24h) up to day 10

Awards & highlights

Study Summary

"This trial is testing a new solution called Prismocitrate 18, which is used during continuous renal replacement therapy to replace the function of the kidneys and prevent blood clotting in the machine. The

Who is the study for?

Adults (18+) needing continuous renal replacement therapy (CRRT) for acute kidney injury, who can't use heparin due to bleeding risks or other contraindications. They must be expected to live at least 24 hours and give written consent.Check my eligibility

What is being tested?

Prismocitrate 18 is being tested as a CRRT solution that also prevents blood clots during treatment. The study will see if it's safe when used with specific CRRT methods over up to 10 days.See study design

What are the potential side effects?

Possible side effects may include issues related to electrolyte imbalances like low calcium levels due to citrate use, metabolic alkalosis, and complications from prolonged anticoagulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (<=6 hours prior to day 1 initiation of crrt); day 1 (1 hour after initiation of crrt, 1 hour after any prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (<=6 hours prior to day 1 initiation of crrt); day 1 (1 hour after initiation of crrt, 1 hour after any prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (<=6 hours prior to day 1 initiation of crrt); day 1 (1 hour after initiation of crrt, 1 hour after any prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with symptomatic citrate accumulation

Number of participants with symptomatic hypercalcemia

Number of participants with symptomatic hypocalcemia

Secondary outcome measures

Extracorporeal Circuit Life

Lab measurement for Base Excess by Time Point

Lab measurement for Phosphate by Time Point

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prismocitrate 18Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baxter Healthcare CorporationLead Sponsor

315 Previous Clinical Trials

200,028 Total Patients Enrolled

2 Trials studying Continuous Renal Replacement Therapy

634 Patients Enrolled for Continuous Renal Replacement Therapy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many diverse venues is this experimental examination currently being conducted?

"Currently, this research is ongoing at 8 different medical facilities including those in Newark, Pittsburgh, and Chattanooga. It is advisable to choose a site closest to you to reduce travel obligations should you decide to take part."

Answered by AI

Has Prismocitrate 18 received official approval from the FDA?

"Our team at Power has assigned a safety rating of 3 to Prismocitrate 18 based on the Phase 3 trial stage, indicating that there is evidence supporting both its effectiveness and safety from several data collection rounds."

Answered by AI

Is the enrollment for participants in this study currently ongoing?

"According to clinicaltrials.gov, this investigation is actively enrolling volunteers. It was initially listed on 4/1/2024 and last modified on 4/13/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

2024. "Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05399537.