Health TrialsbyHealthPanel

Early Norepinephrine Administration and Rapid Dose Adjustment

ConditionsSepsisSeptic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock.

The main questions it aims to answer are:

* Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment? * Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events?

Researchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes.

Participants will:

* Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol * Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation * Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated * Be followed for clinical outcomes and adverse events for up to 28 days after enrollment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Sepsis: SOFA ≥2 with suspected infection

Mean arterial pressure <65 mmHg

Diagnosed within 3 hours

Disqualifiers

Do-not-resuscitate orders

Pregnancy

Severe concurrent conditions (acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, and fatal drug overdose, End-stage malignancy

Peripheral arterial disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early norepinephrine administration and rapid dose adjustment

    Drug

    Norepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP \<65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes. Duration: 24 hours.

  • Control

    Drug

    Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day survival

Survival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days.

Time frame
From enrollment to 28 days after enrollment

Secondary outcomes

1

Number of participants with shock control achieved

Shock control defined as mean arterial pressure greater than 65 mmHg combined with urine output greater than 0.5 milliliters per kilogram per hour OR lactate clearance greater than 10 percent within 6 hours

Time frame
From enrollment to 6 hours after enrollment
2

Duration of intensive care unit stay

Days of intensive care unit stay

Time frame
From enrollment to hospital discharge or 90 days (whichever comes first)
3

Duration of hospital stay

Days of hospital stay

Time frame
From enrollment to hospital discharge or 90 days (whichever comes first)
4

Duration of mechanical ventilation

Days on mechanical ventilation, including endotracheal tube and tracheostomy

Time frame
From enrollment to hospital discharge or 90 days (whichever comes first)

Other outcomes

Sponsors and contacts

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

Siriraj Hospital

Lead sponsor

Maharaj Nakorn Si Thammarat

Collaborator

Kalasin Hospital

Collaborator

Khon Kaen Hospital

Collaborator

Udon Thani Regional Hospital

Collaborator

Hat Yai Hospital

Collaborator

Source ClinicalTrials.gov
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