Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

Not Applicable

Recruiting

• Conditions: Norepinephrine; Hemorrhagic Shock; Hypotensive Resuscitation
• Interventions: Drug: Low dose of Norepinephrine (NE); Drug: High dose of Norepinephrine (NE)

• Registration Number: NCT06311903
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-09
• Study First Submitted QC: 2024-03-09
• Last Update Submitted: 2024-03-09
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	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 norepinephrine (NE) (0.05-0.2 μg/kg/min).
Group II	High dose of Norepinephrine (NE)	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).

Primary Outcome Measures

Name	Time	Method
24 hours mortality	24 hours after intervention	24 hours mortality will be measured.

Secondary Outcome Measures

Name	Time	Method
Length of intensive care unit stay	28 days after intervention	Length of intensive care unit (ICU) stay will be measured from admission till intensive care discharge.
28 day mortality	28 days after intervention	28 day mortality will be measured.
Incidence of acute kidney injury	24 hours after intervention	Incidence of acute kidney injury will be measured within 24 hours.
Length of hospital stay	28 days after intervention	Length of hospital stay will be measured from admission till hospital discharge.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt