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Pre-dilution (PRISE) Study in Severe Sepsis

A Randomized Controlled Trial on the Effects of a Pre-dilution Method to Prolong Filter Life During Continuous Renal Replacement Therapy in Severe Sepsis, and an Observational Study on Inflammatory Response (PRISE Study) - Pre-Dilution CRRT in Sepsis (PRISE) Study(PRISE)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052250105
Enrollment
80
Registered
2025-09-08
Start date
2025-11-12
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe sepsis-induced acute renal dysfunction

Interventions

arn A (new treatment group): Continuous renal replacement therapy will be performed using the pre-dilution method, with a filtrate flow rate of 300 mL/hr for 48 hours or the initial CRRT circuit will

Sponsors

Shinozaki Koichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) patients aged 18 years or older at the time of obtaining consent (2) patients who have given written consent to participate in the study of their own free will, or, if the patient lacks the capacity to consent, a surrogate (3) patients with severe sepsis or septic shock (4) patients with acute kidney injury corresponding to AKI stage 1 or higher according to KDIGO, or patients who are deemed to be absolute candidates for CRRT for any of the following reasons 1 serum urea nitrogen level>150 mg/dl 2 serum potassium level>6 mmol/l 3 blood ph<7.15 4 Urine output < 200 mL/12 hr 5 Edema with diuretic-resistant acute kidney injury

Exclusion criteria

Exclusion criteria: (1) Patients with an increased risk of bleeding, patients with diseases associated with hemorrhagic diathesis, or patients who require therapeutic anticoagulation (2) Patients with a history of allergy to anticoagulants or hemofiltration devices (3) Patients with heparin-induced thrombocytopenia (4) Patients with acute kidney injury due to permanent occlusion or surgical lesions of both renal arteries (5) Patients with acute kidney injury due to urinary tract obstruction (6) Patients who have undergone kidney transplantation within the past 12 months from the time of enrollment (7) Patients with DNAR at the time of enrollment (8) Patients with a conflict of interest with the researcher or sponsor (9) Female patients who are pregnant, or breastfeeding (10) Those whose identity as study subjects is unknown

Design outcomes

Primary

MeasureTime frame
filter lifes of CRRT

Secondary

MeasureTime frame
(1) Patient Outcomes:Survival time (days),90-day and 30-day survival rates,survival to discharge, and recovery rate from acute kidney injury (AKI). (2) Adverse Events:Incidence of hypotension, hemorrhage, new infections, and other adverse events categorized as moderate or higher in severity. (3) Other:24-hour filter life (hours),Circuit pressure (outlet pressure, inlet pressure (filter pressure), filtration pressure, return pressure (venous pressure), TMP (transmembrane pressure)),type and dose of anticoagulant during CRRT session, qualitative analysis of blood clot volume in deaeration chamber,Electron microscopy image examination of filter (White blood cell count), IL-6 level in blood, and insertionsite of intravascular catheter (right internal jugularvein, left internal jugular vein, right femoral vein, left femoral vein, other).

Contacts

Public ContactKoichiro Shinozaki

Kindai University Hospital

khgrac.info@med.kindai.ac.jp+81-72-288-7222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026