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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06311903
Other study ID # 36264PR430/11/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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