Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Norepinephrine Hemorrhagic Shock Hypotensive Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I

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).

Group Type EXPERIMENTAL

Low dose of Norepinephrine (NE)

Intervention Type DRUG

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 NE (0.05-0.2 μg/kg/min).

Group II

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).

Group Type EXPERIMENTAL

High dose of Norepinephrine (NE)

Intervention Type DRUG

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

Interventions

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Low dose of Norepinephrine (NE)

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 NE (0.05-0.2 μg/kg/min).

Intervention Type DRUG

High dose of Norepinephrine (NE)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No