New blood thinner may improve dialysis outcomes in sepsis patients
NCT ID NCT07518303
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study compares two blood thinners used during continuous dialysis in adults with sepsis and acute kidney injury. About 1,162 participants will receive either nafamostat mesylate or standard citrate anticoagulation. The main goal is to see which approach reduces death, ongoing dialysis need, or persistent kidney problems within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nafamostat mesylate
- What this could lead to
- If nafamostat works better than citrate, it could reduce death, kidney failure, or the need for ongoing dialysis in sepsis patients.
- What could go wrong
- This is a phase 4 trial, but results may not apply to all patients. Nafamostat could cause bleeding or other side effects, and the benefit over citrate is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,162 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 90 years, inclusive, regardless of sex. * Meets Sepsis 3.0 diagnostic criteria and develops acute kidney injury within 7 days after the diagnosis of sepsis. * After adequate resuscitation, meets KDIGO 2012 stage 2 or stage 3 acute kidney injury criteria, including any of the following: Serum creatinine increased to more than 3 times baseline; or Serum creatinine ≥4.0 mg/dL \[353.6 μmol/L\]; or Urine output \<0.3 mL/kg/h for ≥24 hours; or Anuria, defined as extremely low or absent urine output, lasting ≥12 hours. Or has an indication for CRRT, including any of the following: Blood urea nitrogen \>150 mg/dL; or Serum potassium \>6 mmol/L; or pH \<7.15; or Organ edema and/or fluid overload in the setting of AKI that is refractory to diuretic therapy. * Expected duration of CRRT treatment \>48 hours. * Written informed consent obtained. Exclusion Criteria: * Requirement for therapeutic anticoagulation, such as pulmonary embolism or deep vein thrombosis. * Contraindication to systemic anticoagulation. * Hemolytic uremic syndrome or thrombotic thrombocytopenic purpura. * Acute liver failure and/or shock with persistent severe lactic acidosis, defined as two consecutive measurements of pH \<7.2 lasting for more than 2 hours, with lactate \>72.1 mg/dL \[8 mmol/L\]. * Chronic kidney disease requiring long-term regular dialysis. * Acute kidney injury caused by permanent bilateral renal artery occlusion or surgical injury. * Acute kidney injury caused by glomerulonephritis, interstitial nephritis, or vasculitis. * Known allergy to study drugs, including nafamostat mesylate, sodium citrate, or their excipients. * Kidney transplantation within 1 year. * Planning pregnancy in the near term, pregnancy, or lactation. * HIV infection. * Only adsorptive filters such as oXiris are available at study enrollment. * Participation in another clinical trial within the previous 3 months. * Judged by the investigator to be in a moribund state or unlikely to complete the study intervention and primary outcome assessment, including but not limited to expected death within 24 hours after enrollment, decision for do-not-resuscitate order or limitation/withdrawal of life-sustaining treatment, or planned abandonment of active treatment and self-discharge within 24 hours due to terminal disease or patient/family preference. * Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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