Early Administration of Norepinephrine in Sepsis
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Sepsis, Severe
In brief
The management of septic states includes, in addition to the specific treatment (antimicrobials and eradication of the source), a restoration of the hemodynamic disorders and assistance of the failing organs. In general, the restoration of hemodynamic disorders begins first with volume expansion, followed by the use of Noepinephrine (NE) when the target mean arterial pressure (MAP) is not reached after optimizing the intravascular volume. Recently, several studies have supported the interest of early NE on MAP, cardiac output and mortality. It is therefore tempting to restrict fluid administration even in the initial phase of hemodynamic management of severe sepsis by starting NE earlier.
Key facts
- Study ID
- NCT05836272
- Run by
- Tunis University
- People needed
- 200
- Starts
- 2023-08-01
- Expected to finish
- 2025-08-01
- Last updated by the study team
- 2024-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- intensive care unit of the University Hospital Center La Rabta — Tunis, Tunisia (enrolling)
Full record on ClinicalTrials.gov
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