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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774054
• Other study ID #: early noradrenaline in sepsis
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 10, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Tanta university	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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