Clinical trial

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

Name

Tunisian ICUs association

Description

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.

Trial arms

Trial start

2023-08-01

Estimated PCD

2024-09-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Norepinephrine Bitartrate

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.

Arms:

Early NE

Other names:

Norepinephrine 0,016 mg/ml

Placebo

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.

Arms:

Placebo

Size

200

Primary endpoint

shock control

within 6 hours

Eligibility 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,

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This involves randomizing 2 independent groups according to a succession of six blocks of random permutations and this will be carried out using a computer-generated tool: the NE group (early noradrenaline group) which will receive NA at start for correction of hypotension and Placebo group (standard treatment group).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2023-08-29

1 organization

1 product

2 indications

Organization

Tunis University

Product

Norepinephrine Bitartrate

Indication

Sepsis

Indication

Severe