Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock

Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock (NCT06471231) is a Phase 4 interventional studying Septic Shock and Renal Function Replacement, sponsored by Azienda Usl di Bologna. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 264 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Septic Shock subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - patients suffering from septic shock hospitalized in an intensive setting - patients over 18 years and under 80 years of age - patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW) - patients capable of expressing willing to sign a consent form to treatment. Who Should NOT Join This Trial: - patients in the absence of consent to participate in the study and to the processing of personal and particular data; - patients under 18 years of age or over 80 years of age; - patients who died within the first 24 hours of admission to the ICU; - patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU; - patients with recent acute coronary syndrome (within the previous 7 days); - patients with allergy/intolerance to the drugs used in the study or to any component of the study drug including excipients; - pregnant patients; - breastfeeding individuals; - patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred; - patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration \< 30 ml/min); - single kidney patients; - patients with bilateral renal hypoplasia; - patients undergoing kidney transplant; - patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * patients suffering from septic shock hospitalized in an intensive setting * patients over 18 years and under 80 years of age * patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW) * patients capable of expressing informed consent to treatment. Exclusion Criteria: * patients in the absence of consent to participate in the study and to the processing of personal and particular data; * patients under 18 years of age or over 80 years of age; * patients who died within the first 24 hours of admission to the ICU; * patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU; * patients with recent acute coronary syndrome (within the previous 7 days); * patients with allergy/intolerance to the drugs used in the study or to any component of the study drug including excipients; * pregnant patients; * breastfeeding individuals; * patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred; * patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration \< 30 ml/min); * single kidney patients; * patients with bilateral renal hypoplasia; * patients undergoing kidney transplant; * patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin.

Treatments Being Tested

DRUG

vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min

when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure \>65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.

DRUG

vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min

the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Azienda Unità Sanitaria Locale

Bologna, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06471231), the sponsor (Azienda Usl di Bologna), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06471231 clinical trial studying?

Who can participate in NCT06471231?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06471231?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06471231. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06471231. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.