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

NCT ID: NCT05774054

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-03-10

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

Detailed Description

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

. When mean arterial pressure (MAP) falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure. Fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase, as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine (NE)- as a first-line drug aiming to restore vascular tone to assure organ perfusion

. Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility

. Nevertheless, a large amount of fluids will increase the risk of fluid overload, which is a common complication during septic shock resuscitation

• After the early phase, only fifty percent of patients respond to fluid administration, meaning that fluid treatment cannot boost cardiac output (CO) The current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor; however, a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed

Conditions

Norepinephrine; Sepsis; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

Crystalloid

Intervention Type: 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

B

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

Group Type: ACTIVE_COMPARATOR

noradrenaline

Intervention Type: DRUG

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

Interventions

Crystalloid

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

Intervention Type: DRUG

noradrenaline

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

Intervention Type: DRUG

Other Intervention Names

late noradrenaline infusion; early noradrenaline infusion

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

tarek abdel hay mostafa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada elbarady, MD

Role: STUDY_DIRECTOR

tanta university, faculty of medicine

Locations

Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

early noradrenaline in sepsis

Identifier Type: -

Identifier Source: org_study_id