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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05774054
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
22.3
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Feb 1, 2023
Actual Study Completion Date :
Mar 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

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
Other Names:
  • late noradrenaline infusion

    		•
    Active Comparator: B

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine, Tanta university Tanta El Gharbyia Egypt 31111

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Study Director: ghada elbarady, MD, tanta university, faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    tarek abdel hay mostafa, principle investigator, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05774054
    Other Study ID Numbers:
    • early noradrenaline in sepsis
    First Posted:
    Mar 17, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Hypotension
    Norepinephrine

    Study Results

    No Results Posted as of Mar 24, 2023