NCT07053163

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 11, 2025

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

June 27, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

NorepinephrineMortalityTraumatic PatientHemorrhagic Shock

Outcome Measures

Primary Outcomes (1)

  • Mortality

    at first 24 hour

Secondary Outcomes (1)

  • total fluid intake

    at first 24 hour

Study Arms (2)

Crystalloid and blood as resuscitation

EXPERIMENTAL

Patients receive crystalloid and blood as resuscitation.

Drug: Crystalloid and blood as resuscitation

Crystalloid& blood and low dose of norepinephrine

EXPERIMENTAL

receive crystalloid, blood and low dose of norepinephrine.

Drug: crystalloid, blood and low dose of norepinephrine

Interventions

Patients receive crystalloid and blood as resuscitation

Crystalloid and blood as resuscitation

Group 2: receive crystalloid, blood and low dose of norepinephrine

Crystalloid& blood and low dose of norepinephrine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 -65 Years old.
  • Multiple organ injury.
  • Recent trauma within 1st 24 hour.
  • Mean arterial blood pressure \<65 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Crystalloid SolutionsBlood Specimen CollectionResuscitationNorepinephrine

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical PreparationsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEmergency TreatmentTherapeuticsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Radwa Abdeldayem, Resident

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

August 30, 2024

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

July 11, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Locations