New study aims to personalize septic shock treatment with biomarkers
NCT ID NCT05824767
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This completed pilot study tested whether two biomarkers (renin and DPP3) can predict how well patients with septic shock respond to angiotensin II, a drug that raises blood pressure. Forty adults with persistent low blood pressure despite standard treatment were randomly assigned to receive either angiotensin II or usual care. The main goal was to see if baseline biomarker levels could predict the amount of other blood pressure medications needed after 3 hours.
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 successful, this could help doctors predict which septic shock patients will respond best to angiotensin II, potentially improving treatment decisions.
- What could go wrong
- This is a small, early pilot study with only 40 patients, so results may not apply broadly. The study is unblinded, which can introduce bias.
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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42 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Mar 2025
- 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
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18 years and older
- 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: * Adult patients ≥18 years-old with persistent vasodilatory shock despite moderate-dose norepinephrine monotherapy, defined as those who require ≥0.1 mcg/kg/min for at least 30 minutes to maintain a MAP between 65-70 mmHg. * Patients are required to have central venous and arterial catheters present, and they are expected to remain in place for at least the initial 72 hours of study. * Patients are required to have an indwelling urinary catheter present, and it is expected to remain in place for at least the 72 hours of study. * Patients must have received 20-30 mL/kg of crystalloid over the previous 24-hour period, as clinically appropriate, and no longer be fluid responsive as per UNMH protocol. By UNMH protocol, lack of fluid responsiveness is considered a failure to increase stroke volume, stroke volume index, cardiac output, or cardiac index (typically measured by non-calibrated pulse contour analysis using a FloTrac device) by at least 10% after a 500-mL crystalloid bolus or a passive leg raise. Patients for whom the treating physicians feel that 20 mL/kg of crystalloid may be clinically inappropriate can qualify for the study if the reason for withholding further IV fluids is documented. * Patient or (in patients unable to consent) legal authorized representative (LAR) is willing and able to provide written informed consent and comply with all protocol requirements. * Approval from the attending physician and clinical pharmacist conducting the study. Exclusion Criteria: * Patients who are \< 18 years of age. * Patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock. * Patients with or suspected to have abdominal aortic aneurysm or aortic dissection. * Acute stroke. * Patients with acute mesenteric ischemia or those with a history of mesenteric ischemia. * Patients with known Raynaud's phenomenon, systemic sclerosis, or vasospastic disease. * Patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO). * Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score of =/\>30. * Patients with burns covering \>20% of total body surface area. * Patients with a history of asthma or chronic obstructive pulmonary disease (COPD) with active acute bronchospasm or (if not mechanically ventilated) with an acute exacerbation of their asthma/COPD requiring the use of inhaled bronchodilators. * Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose. * Patients with an absolute neutrophil count (ANC) of \< 1,000/mm3 * Patients with hemorrhagic shock OR active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of \>4 units of packed red blood cells. * Patients with active bleeding AND hemoglobin \< 7g/dL or any other condition that would contraindicate serial blood sampling. * Untreated venous thromboembolism (VTE) or inability to tolerate pharmacologic VTE prophylaxis. * Patients with a known allergy to mannitol. * Patients with an expected survival of \<24 hours, SOFA score ≥ 16, or death deemed to be imminent or inevitable during the admission. * Either the attending physician or patient and/or substitute decisionmaker are not committed to all active treatment, e.g., do-not-resuscitate (DNR) status. * Patients who are known to be pregnant at the time of screening. All women ≤50 years-old will need a negative serum pregnancy test (serum quantitative beta-hCG) to enroll. * Prisoner status * Patients who are currently participating in another interventional clinical trial.
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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.
Contacts and locations
Locations
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?