The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension

NCT05774054 | Completed DMC

• 1 other identifier: early noradrenaline in sepsis
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of \> 2 mmol/L (18 mg/dL) despite sufficient volume resuscitation . Hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock

Conditions

Norepinephrine; Sepsis; Hypotension

Outcome Measures

Primary Outcomes (1)

• the required duration to achieve the target MAP

  time to achieve target mean arterial pressure over or equal to 65 mmHg once the diagnosis of sepsis is confirmed, is the target to stop fluid management.

  24 hours since the diagnosis of sepsis

Study Arms (2)

A

ACTIVE COMPARATOR

patients received (30ml /kg) ringer's lactate solution after first presentation then norepinephrine was added when persistent mean arterial pressure (MAP)\> 65 mmHg despite adequate fluid resuscitation

Drug: Crystalloid

B

ACTIVE COMPARATOR

patients received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)

Drug: noradrenaline

Interventions

Crystalloid DRUG

received (30ml /kg) ringer's lactate solution after first presentation then norepinephrine was added when persistent mean arterial pressure (MAP)\> 65 mmHg despite adequate fluid resuscitation

Also known as: late noradrenaline infusion

A

noradrenaline DRUG

received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)

Also known as: early noradrenaline infusion

B

Eligibility Criteria

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

You may qualify if:

• Adult patients aged from18 to 65 years old
• had the diagnostic criteria for sepsis as the presence of infection
• systemic manifestations of infection and signs of Hypoperfusion

You may not qualify if:

• Acute cerebral vascular event
• Active cardiac conditions
• Valvular heart diseases
• Hypotension suspected to be due to another cause and comorbidities
• Status asthmatics
• Active hemorrhage
• Pregnancy
• Burn injury
• Requirement for immediate surgery
• Advanced-stage cancer
• Refusal to participate in the study

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Sepsis; Hypotension

Interventions

Crystalloid Solutions; Norepinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• ghada elbarady, MD

  tanta university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: May 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 10, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)