Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

Is Low Dose Norepinephrine Effective in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock?

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

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Shock; Norepinephrine; Hypotensive Resuscitation
• Intervention / Treatment: Drug: Low dose of Norepinephrine (NE); Drug: High dose of Norepinephrine (NE)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabab M Mohamed, MD; Phone Number: 00201069122935; Email: rabmoh_30@outlook.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Rabab M Mohamed, MD; Phone Number: 00201069122935; Email: rabmoh_30@outlook.com
      • Principal Investigator: Atia G Anwar, MD
      • Principal Investigator: Ahmed A Eid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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).
Experimental: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hours mortality	24 hours mortality will be measured.	24 hours after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 9, 2024
• First Submitted That Met QC Criteria: March 9, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Shock; Shock, Hemorrhagic; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: 36264PR430/11/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No