Low Dose of Norepinephrine Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock

NCT ID: NCT07053163

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2024-09-30

Brief Summary

The aim of the work is to evaluate role of low dose of nor epinephrine administration in the early 24-hour period among traumatic patients and hemorrhagic shock. The primary outcome: evaluate mortality at first 24 hour. The secondary outcome : measure total fluid intake, observe renal functions and Hemodynamic changes.

Detailed Description

Uncontrolled hemorrhage remains the leading cause of preventable death among patients with trauma, despite considerable improvements in trauma care Trauma- induced hemorrhage and hypovolemia can trigger an increase neurohormonal response and hypotension is not explained by hypovolemia alone but is associated with sympathy inhibitory-induced vasodilation. Trauma was defined as any exposure to nonpenetrating or penetrating kinetic energy, collision, or deceleration, Patients were alive on admission with hemorrhagic shock, defined by prehospital or admission mean arterial blood pressure less than 65 mm Hg. Management of shock after trauma remains a clinical challenge, in particular if associated with active hemorrhage and vasopressors are part of the recommended therapeutic routinely used by clinicians in Europe . Historically, the importance of permissive hypotension and the restriction of crystalloid fluid volume before hemorrhage control has been confirmed with good outcomes in patients with penetrating trauma.

Vasopressors mimic the initial response to blood loss; improve venous return, coronary perfusion, and myocardial contractility. Generally, vasopressors are considered to have a negative impact on patient outcome in the management of hemorrhagic Shock, and the predominant strategy is based on permissive hypotension and low volume resuscitation.

vasopressor use in hemorrhagic Shock in humans. The use of vasopressors, such as norepinephrine for the hemodynamic management of hemorrhagic shock, may be considered in the early phase of resuscitation and is a common practice among several prehospital and hospital emergency teams in Europe. Where any surgical or interventional radiographic procedures for the immediate control of bleeding and early activation of massive transfusion protocol are always not available, the effects vasopressor administration for severe hemorrhagic shock following trauma is used to restore arterial pressure in hemorrhagic shock. Norepinephrine is a sympathomimetic agent with predominantly vasoconstrictive effects. Norepinephrine exerts both arterial and venous α-adrenergic stimulation.

Conditions

Mortality Rate; Hemorrhagic Shock

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Crystalloid and blood as resuscitation

Patients receive crystalloid and blood as resuscitation.

Group Type: EXPERIMENTAL

Crystalloid and blood as resuscitation

Intervention Type: DRUG

Patients receive crystalloid and blood as resuscitation

Crystalloid& blood and low dose of norepinephrine

receive crystalloid, blood and low dose of norepinephrine.

Group Type: EXPERIMENTAL

crystalloid, blood and low dose of norepinephrine

Intervention Type: DRUG

Group 2: receive crystalloid, blood and low dose of norepinephrine

Interventions

Crystalloid and blood as resuscitation

Patients receive crystalloid and blood as resuscitation

Intervention Type: DRUG

crystalloid, blood and low dose of norepinephrine

Group 2: receive crystalloid, blood and low dose of norepinephrine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients 18 -65 Years old.
• Multiple organ injury.
• Recent trauma within 1st 24 hour.
• Mean arterial blood pressure <65 mmHg

Exclusion Criteria

• Cardiac arrest at admission.
• Old trauma more than 24 hour.
• Severe brain or spinal injury (because of different target blood pressures).
• Death due to haemostatic failure within 6 hours of admission

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Gamal Said Abdeldayem

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa Abdeldayem, Resident

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

36264MS298/8/24

Identifier Type: -

Identifier Source: org_study_id