Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

Hemorrhagic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311903
• Other study ID #: 36264PR430/11/23
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: Rabab M Mohamed, MD
• Phone: 00201069122935
• Email: rabmoh_30[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Hypotension
• Shock
• Shock, Hemorrhagic

Intervention

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).
• 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).

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours mortality	24 hours mortality will be measured.	24 hours after intervention
Secondary	28 day mortality	28 day mortality will be measured.	28 days after intervention
Secondary	Incidence of acute kidney injury	Incidence of acute kidney injury will be measured within 24 hours.	24 hours after intervention
Secondary	Length of hospital stay	Length of hospital stay will be measured from admission till hospital discharge.	28 days after intervention
Secondary	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