Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

Tanta University

Status: Enrolling

Conditions: Norepinephrine; Hypotensive Resuscitation; Hemorrhagic Shock

Treatments: Drug: High dose of Norepinephrine (NE); Drug: Low dose of Norepinephrine (NE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06311903

36264PR430/11/23

Details and patient eligibility

About

The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock.

Full description

Hemorrhagic shock is one of the leading causes of death following trauma. New fluid resuscitation concepts, including hypotensive, hypothermic, and delayed resuscitation for uncontrolled hemorrhagic shock, have been put forward and obtained a good effect both in clinical and laboratory parameters. The 2019 European guideline on the management of major bleeding and coagulopathy following trauma recommends the use of norepinephrine (NE) for maintaining target arterial blood pressure in patients with life-threatening hypotension. NE has potent α-adrenergic receptor activation activity, which can stimulate α-1 adrenergic receptors on peripheral vascular smooth muscles. High-dose NE may result in excessive arteriolar vasoconstriction which subsequently leads to the disorder of microcirculation and tissue hypoxia.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old.
• Both sexes.
• Patients with hemorrhagic shock

Exclusion criteria

• Patients with cardiac arrest at admission.
• Severe brain.
• Spinal injury (because of different target blood pressures).
• Death due to hemostatic failure within 6 h of admission.
• Pregnancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group I

Experimental group

Description:

Patients were received resuscitative fluid \[administered at beginning with the arrival of the patient in the emergency department (mean blood pressure \>70 mmHg)\] followed by low dose of norepinephrine (NE) (0.05-0.2 μg/kg/min).

Treatment:

Drug: Low dose of Norepinephrine (NE)

Group II

Experimental group

Description:

patients were received resuscitative fluid. If there were no response to treatment to resuscitative fluid, they received norepinephrine (NE) gradually till reach high dose (≥0.3 μg/kg/min).

Treatment:

Drug: High dose of Norepinephrine (NE)