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Could a targeted drug beat standard care for shock in liver patients?

NCT ID NCT07568275

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a drug called Angiotensin II can raise blood pressure more effectively than standard medications in people with liver cirrhosis who have septic shock. Researchers will measure how well the heart and blood vessels work together over 24 hours. The trial involves 30 participants and is in an early phase, so results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Angiotensin II (Giapreza)
What this could lead to
If it works, this could point toward a better way to manage dangerous low blood pressure in people with liver disease and sepsis.
What could go wrong
This is a very early, small study with only 30 participants, so results may not apply broadly. The drug may not work better than current treatments and could have side effects.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

30 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Jan 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 years and older

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 years at the time of enrollment * Septic shock as defined by Sepsis-3 criteria (highly suspected or confirmed infection, requiring norepinephrine to maintain a MAP ≥ 65 mmHg, and serum lactate \> 2 mmol/L after adequate fluid resuscitation) within a 48 hour window prior to enrollment * Confirmed cirrhotic patient (Radiological/Biopsy/Physician confirmed) * Preserved cardiac function as assessed using point-of-care ultrasonography or a non-invasive hemodynamic monitoring device with either LVOT VTI \> 18 cm or stroke volume \> 50 ml Within 48 hours of onset of shock. * Standard of care vasopressors are at a norepinephrine equivalent of 15 mcg/min Exclusion Criteria: * Declined consent. * Pregnancy * CKD-Stage IV/V * ESRD on long-term hemodialysis * On Dialysis or planned dialysis to be initiated within 24 hours of study of enrollment. * Clinically determined to have primarily hepatorenal syndrome. * On other vasoactive medication (phenylephrine, Terlipressin, epinephrine, dobutamine, dopamine) * Hemorrhagic, obstructive, or hypovolemic shock is not the primary cause of shock based on clinical judgement. * DNR * Patients declared Brain dead. * Anticipated death within 48 hours of enrollment * Echocardiographic windows not available * Acute mesenteric Ischemia * Active gastrointestinal bleeding * Active cardiac ischemic event defined as NSTEMi, STEMI * Acute DVT/Pulmonary embolism/Portal vein thrombosis * \> 48 h since initiation of vasopressor agent * Cardiac function assessment show LVOT VTI \< 18 cm or stroke volume \< 50 ml/min * Norepinephrine equivalent dose \> 50mcg/min

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Conditions

The condition(s) this trial relates to.

acute kidney injury cirrhosis of liver Fibrosis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Cirrhosis Septic shock Vasodilatory shock

Contacts and locations

Locations

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.