Clinical trial

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

NCT06311903

Name

36264PR430/11/23

Description

The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock.

Trial arms

Trial start

2023-12-01

Estimated PCD

2024-04-01

Trial end

2024-04-01

Status

Recruiting

Treatment

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).

Arms:

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).

Arms:

Group II

Size

200

Primary endpoint

24 hours mortality

24 hours after intervention

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication

Hypotensive Resuscitation