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New blood thinner may improve dialysis outcomes in sepsis patients

NCT ID NCT07518303

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,162 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 90 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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