Early Administration of Norepinephrine in Sepsis

ConditionSepsis, Severe

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorTunis University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Norepinephrine Bitartrate
Drug
The NE will be prepared as follows: 4 mg mixed with 250 ml of 5% glucose resulting in a final norepinephrine concentration of 0.016 mg/ml. For the control group placebo: 250 ml of 5% glucose will be prepared. Both drugs will be infused via a peripheral line or a venous catheter. The intravenous infusion rate varies from 8 to 15 ml/hour, adjusted according to body weight to obtain norepinephrine at 0.05 microgram/kg/min (ie 0.128 to 0.24 mg per hour) in continuous infusion.
Placebo
Other intervention
For the control group placebo: 250 ml of 5% glucose will be prepared and will be infused via a peripheral line or a venous catheter. The intravenous infusion rate varies from 8 to 15 ml/hour.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Early NEActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

shock control

shock control is defined by a composite criterion (MAP \> 65 mm Hg for 2 consecutive measurements and urinary output \> 0.5 ml/kg/h for 2 consecutive hours)

Time frame

within 6 hours

Secondary outcomes

Decrease in serum lactate

Decrease in serum lactate \> 10% from baseline

Time frame

within 6 hours

Volume of fluid

Quantity of intravenous fluid received

Time frame

within 48 hours

Mortality

Time frame

28 days

Other outcomes

Use of invasive ventilation

Time frame

48 hours

Variation of cardiac output

Variation of Cardiac output assessed xith transthoracic cardiac ultrasound (the 15% threshold is considered to define an increase in CO).

Time frame

Within 6 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tunis University

Lead sponsor

Source ClinicalTrials.gov

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