Early Administration of Norepinephrine in Sepsis (Tunisian Multicenter Randomized Trial)

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
Tunisia
intensive care unit of the University Hospital Center La Rabta
RECRUITING
Tunis
Contact Information
Primary
Ahlem Trifi
trifiahlem2@gmail.com
98692699
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 200
Treatments
Active_comparator: Early NE
The early NE arm will receive low-dose NE as soon as hypotension secondary to sepsis is observed in addition to a classic therapeutic regimen that complies with the guidelines of the 2021 Surviving Sepsis Compaign. Sepsis is defined according to the sepsis 3 consensus by a sepsis related organ failure assessment (SrOFA) score greater than 2 following an infection (documented or suspected)
Placebo_comparator: Placebo
The placebo arm will receive only the classic therapeutic regimen that complies with the guidelines of the 2021 Surviving Sepsis Compaign.
Related Therapeutic Areas
Sponsors
Leads: Tunis University

This content was sourced from clinicaltrials.gov