Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock

NCT06311903 | Recruiting

• 1 other identifier: 36264PR430/11/23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Norepinephrine; Hemorrhagic Shock; Hypotensive Resuscitation

Outcome Measures

Primary Outcomes (1)

• 24 hours mortality

  24 hours mortality will be measured.

  24 hours after intervention

Secondary Outcomes (4)

• 28 day mortality

  28 days after intervention

• Incidence of acute kidney injury

  24 hours after intervention

• Length of hospital stay

  28 days after intervention

• Length of intensive care unit stay

  28 days after intervention

Study Arms (2)

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).

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).

Drug: High dose of Norepinephrine (NE)

Interventions

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).

Group II

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).

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Both sexes.
• Patients with hemorrhagic shock

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Rabab M Mohamed, MD

CONTACT

00201069122935; rabmoh_30@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)