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

Primary Purpose

Norepinephrine, Sepsis, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Crystalloid
noradrenaline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Norepinephrine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, Tanta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
March 23, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05774054
Brief Title
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Official Title
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norepinephrine, Sepsis, Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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
Arm Title
B
Arm Type
Active Comparator
Arm Description
patients received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)
Intervention Type
Drug
Intervention Name(s)
Crystalloid
Other Intervention Name(s)
late noradrenaline infusion
Intervention Description
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
Intervention Name(s)
noradrenaline
Other Intervention Name(s)
early noradrenaline infusion
Intervention Description
received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)
Primary Outcome Measure Information:
Title
the required duration to achieve the target MAP
Description
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.
Time Frame
24 hours since the diagnosis of sepsis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada elbarady, MD
Organizational Affiliation
tanta university, faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, Tanta university
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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