NorepinephrineNCT06311903
Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock
A study testing Low dose of Norepinephrine (NE) and High dose of Norepinephrine (NE) in people with Norepinephrine and Hemorrhagic Shock, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Norepinephrine, Hemorrhagic Shock, Hypotensive Resuscitation
- What is being tested?
- Low dose of Norepinephrine (NE) and High dose of Norepinephrine (NE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Both sexes.
- Patients with hemorrhagic shock
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Rabab M Mohamed, MD, 00201069122935, rabmoh_30@outlook.com
Atia G Anwar, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Norepinephrine, Hemorrhagic Shock, Hypotensive Resuscitation
- Being tested
- Low dose of Norepinephrine (NE), High dose of Norepinephrine (NE)
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of Norepinephrine (NE)Drug
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)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | 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). Receives: Drug: Low dose of Norepinephrine (NE) |
| Group II | Experimental | 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). Receives: Drug: High dose of Norepinephrine (NE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours mortality
24 hours mortality will be measured.
Measured: 24 hours after intervention
Secondary outcomes (4)
28 day mortality
28 day mortality will be measured.
Measured: 28 days after intervention
Incidence of acute kidney injury
Incidence of acute kidney injury will be measured within 24 hours.
Measured: 24 hours after intervention
Length of hospital stay
Length of hospital stay will be measured from admission till hospital discharge.
Measured: 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.
Measured: 28 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NorepinephrineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mohamed Mohamed Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311903
- Sponsor's protocol ID
- 36264PR430/11/23
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Low Dose Norepinephrine Effective in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock?
- ClinicalTrials.gov ID
- NCT06311903
- Acronym / sponsor ID
- 36264PR430/11/23
- Conditions
- Norepinephrine, Hemorrhagic Shock, Hypotensive Resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 15 Mar 2024 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | 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 norepinephrine (NE) (0.05-0.2 μg/kg/min). |
| Group II | Experimental | Drug: High dose of Norepinephrine (NE)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Both sexes.
- Patients with hemorrhagic shock
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 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). | Drug | Group I |
| 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). | Drug | Group II |
Primary outcome
24 hours mortality
Time frame: 24 hours after intervention
24 hours mortality will be measured.
4 secondary outcomes
28 day mortality
Time frame: 28 days after intervention
Incidence of acute kidney injury
Time frame: 24 hours after intervention
Length of hospital stay
Time frame: 28 days after intervention
Length of intensive care unit stay
Time frame: 28 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose of Norepinephrine (NE) and High dose of Norepinephrine (NE) in people with Norepinephrine 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabab M Mohamed, MD (00201069122935, rabmoh_30@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours mortality (time frame: 24 hours after intervention). 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 15 Mar 2024.