Mortality RateNCT07053163
Low Dose of Norepinephrine Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock
A study testing Crystalloid and blood as resuscitation and crystalloid, blood and low dose of norepinephrine in people with Mortality Rate and Hemorrhagic Shock, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mortality Rate, Hemorrhagic Shock
- What is being tested?
- Crystalloid and blood as resuscitation and crystalloid, blood and low dose of norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 -65 Years old.
- Multiple organ injury.
- Recent trauma within 1st 24 hour.
- Mean arterial blood pressure <65 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Low Dose of Norepinephrine Administration Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock
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.
Read the 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
- Being tested
- Crystalloid and blood as resuscitation, crystalloid, blood and low dose of norepinephrine
- Keywords
- Norepinephrine, Mortality, Traumatic Patient, Hemorrhagic Shock
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid and blood as resuscitationDrug
Patients receive crystalloid and blood as resuscitation
crystalloid, blood and low dose of norepinephrineDrug
Group 2: receive crystalloid, blood and low dose of norepinephrine
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid and blood as resuscitation | Experimental | Patients receive crystalloid and blood as resuscitation. Receives: Drug: Crystalloid and blood as resuscitation |
| Crystalloid& blood and low dose of norepinephrine | Experimental | receive crystalloid, blood and low dose of norepinephrine. Receives: Drug: crystalloid, blood and low dose of norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: at first 24 hour
Secondary outcomes (1)
total fluid intake
Measured: at first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Aug 2024
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mortality RateStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Gamal Said Abdeldayem, Tanta University
- Investigators
- Radwa Abdeldayem, Resident, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053163
- Sponsor's protocol ID
- 36264MS298/8/24
- Status last verified
- Sep 2023
- First submitted
- 27 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Dose of Norepinephrine Administration Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT07053163
- Acronym / sponsor ID
- 36264MS298/8/24
- Conditions
- Mortality Rate, Hemorrhagic Shock
- Keywords
- Norepinephrine, Mortality, Traumatic Patient, Hemorrhagic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid and blood as resuscitation | Experimental | Drug: Crystalloid and blood as resuscitationPatients receive crystalloid and blood as resuscitation. |
| Crystalloid& blood and low dose of norepinephrine | Experimental | Drug: crystalloid, blood and low dose of norepinephrinereceive crystalloid, blood and low dose of norepinephrine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 -65 Years old.
- Multiple organ injury.
- Recent trauma within 1st 24 hour.
- Mean arterial blood pressure <65 mmHg
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalloid and blood as resuscitationPatients receive crystalloid and blood as resuscitation | Drug | Crystalloid and blood as resuscitation |
| crystalloid, blood and low dose of norepinephrineGroup 2: receive crystalloid, blood and low dose of norepinephrine | Drug | Crystalloid& blood and low dose of norepinephrine |
Primary outcome
Mortality
Time frame: at first 24 hour
1 secondary outcome
total fluid intake
Time frame: at first 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radwa Abdeldayem, Resident principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid and blood as resuscitation and crystalloid, blood and low dose of norepinephrine in people with Mortality Rate and Hemorrhagic Shock, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: at first 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.