Early use of norepinephrine for treating severe sepsis
Official title: Early Administration of Norepinephrine in Sepsis (Tunisian Multicenter Randomized Trial)
Run by Tunis University · NCT05836272 · Data updated 2026-11-12
This study is testing if giving norepinephrine earlier can help people with severe sepsis feel better and live longer compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Tunis University Academic / other |
| Locations | 1 site (Tunis) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | June 2025 |
| Study ends | August 2025 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT05836272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 or older diagnosed with sepsis and exhibiting a mean arterial pressure below 65 mmHg.
✕Probably not a fit
Patients who are already in septic shock requiring immediate norepinephrine or those with advanced neoplasia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the early administration of norepinephrine in patients with severe sepsis to improve hemodynamic stability and reduce mortality. The study aims to determine if starting norepinephrine earlier than the standard protocol can enhance mean arterial pressure (MAP) and cardiac output, leading to better patient outcomes. Participants will receive either norepinephrine or a placebo, and their responses will be monitored closely. The trial is based on previous findings that suggest early norepinephrine use may significantly improve survival rates in septic patients.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients suffering from severe sepsis.
How similar studies have gone: Previous studies have shown promising results with early norepinephrine administration in sepsis management, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older. * The patient or his/her legal representative has given informed consent in writing. * Diagnosis of sepsis according to the definitions updated by the consensus of sepsis 3. * Mean arterial pressure \< 65 mmHg Exclusion Criteria: * Diagnosis of septic shock prior to randomization (where NA requirements exceed those of the trial protocol) * Pregnancy, * Need for immediate surgery, * Neoplasia at an advanced stage * Circumstances where water restriction is the rule: * Acute pulmonary edema * Acute coronary syndrome,
Where it's running
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intensive care unit of the University Hospital Center La Rabta
Tunis, Tunisia Recruiting
Study contacts
- Principal investigator: Ahlem Trifi — Hopital La Rabta
- Study coordinator: Ahlem Trifi
- Email: trifiahlem2@gmail.com
- Phone: 98692699
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.