Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients

Impact of Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients

This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.

Primary outcome:

• Correlation between peripheral perfusion index

Secondary outcomes:

• Peripheral perfusion index accuracy to predict the tissue perfusion .
• Peripheral perfusion index accuracy to predict mortality.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Peripheral Perfusion Index
• Intervention / Treatment: Drug: Group I: Patients will receive norepinephrine <0.15 µg/kg/min; Drug: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min

Detailed Description

Septic shock is a common cause of intensive care unit admission and one of the major causes of death among intensive care unit inpatients.

It is a complex critical condition associated with a reported mortality rate of up to 30% to 40%.

. It is the most severe form of sepsis with concomitant hemodynamic failure and immune, inflammatory, and metabolic disorders. The resulting circulatory shock finally leads to an alteration of tissue perfusion, causing organ failures and associated poor outcomes.

An essential step in managing patients with septic shock is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure with vasopressors when patients are hypotensive improves the input pressure that drives organ perfusion. Therefore, maintaining organ perfusion in the time course of septic shock is a fundamental goal.

Norepinephrine is a commonly used vasopressor in the management of septic shock. It increases vascular tone and blood pressure, thereby improving systemic perfusion. However, excessive norepinephrine dosing is associated with the risk of extreme vasoconstriction, tissue hypoperfusion, and increased mortality. Peripheral and regional tissue perfusion in patients with septic shock have been extensively studied over the last decade. Indeed, several authors have emphasized the potential benefits of monitoring microcirculatory and regional perfusion parameters to better guide the resuscitation of these patients and give a prognosis. The peripheral perfusion index ,which is defined as the ratio of the pulsatile to non-pulsatile component of the pulse oximetry plethysmograph (peripheral perfusion index = pulsatile signal/ non-pulsatile signal), is used as a simple and accurate indicator of the pulsation intensity of peripheral arterioles .

We hypothesize that peripheral perfusion index could accurately predict tissue perfusion at different doses of norepinephrine in septic shock patients. This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.

Primary outcome:

• Correlation between peripheral perfusion index

Secondary outcomes:

• Peripheral perfusion index accuracy to predict the tissue perfusion .
• Peripheral perfusion index accuracy to predict mortality.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 65 years.
• Both sexes.
• Septic shock patients requiring norepinephrine infusion at dose <0.25 µg/kg/min to achieve mean arterial pressure (Mean arterial blood pressure ≥ 65 mm Hg).

Exclusion Criteria:

• Patients fail to achieve Mean arterial blood ≥ 65 mm Hg or need norepinephrine dose ≥0.25 µg /kg/min.
• Pregnancy.
• Diabetes mellitus.
• Tissue edema.
• Respiratory diseases affecting gas exchange, such as asthma and Chronic Obstructive Pulmonary Disease.
• Sever hypoxemia or hypercarbia.
• Core temperature < 36 ᴼc.
• Body mass index ≥35 kg/m2
• Cardiovascular diseases and pulmonary edema

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients will receive norepinephrine <0.15 µg/kg/minute	Drug: Group I: Patients will receive norepinephrine <0.15 µg/kg/min; Patients will receive norepinephrine <0.15 µg/kg/min
Experimental: Group II; Patients will receive norepinephrine ≥ 0.15 µg/kg/minutes	Drug: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min; Patients will receive norepinephrine ≥ 0.15 µg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance).	Before initiation of vasopressor therapy, 5 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours post-initiation of vasopressor therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean arterial blood pressure	Before the initiation of vasopressor therapy, 5 minutes, 30 minutes,, 1 hour, 2 hours, and 6 hours after the initiation of vasopressor therapy.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Septic Shock; Norepinephrine; Tissue Perfusion; Peripheral Perfusion Index
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: 36264MS735/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be provided when required
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No