Skip to content

Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06311903
Enrollment
200
Registered
2024-03-15
Start date
2023-12-01
Completion date
2024-04-01
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Shock, Hypotensive Resuscitation, Norepinephrine

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.

Interventions

DRUGLow 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).

DRUGHigh 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).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
24 hours mortality24 hours after intervention24 hours mortality will be measured.

Secondary

MeasureTime frameDescription
28 day mortality28 days after intervention28 day mortality will be measured.
Incidence of acute kidney injury24 hours after interventionIncidence of acute kidney injury will be measured within 24 hours.
Length of hospital stay28 days after interventionLength of hospital stay will be measured from admission till hospital discharge.
Length of intensive care unit stay28 days after interventionLength of intensive care unit (ICU) stay will be measured from admission till intensive care discharge.

Countries

Egypt

Contacts

Primary ContactRabab M Mohamed, MD
rabmoh_30@outlook.com00201069122935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026