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

Not Applicable

Completed

• Conditions: Sepsis; Norepinephrine; Hypotension
• Interventions: Drug: Crystalloid; Drug: noradrenaline

• Registration Number: NCT05774054
• Lead Sponsor: Tanta University

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

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study Completion: 2023-03-10
• Study First Posted: 2023-03-17
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Crystalloid	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
B	noradrenaline	patients received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)

Primary Outcome Measures

Name	Time	Method
the required duration to achieve the target MAP	24 hours since the diagnosis of sepsis	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.

Trial Locations

Locations (1)

Faculty of medicine, Tanta university; 🇪🇬 Tanta, El Gharbyia, Egypt