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

NCT07330908 | Completed

• 1 other identifier: 36264MS735/11/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock; Peripheral Perfusion Index

Keywords

Norepinephrine; Peripheral Perfusion Index; Septic Shock; Tissue Perfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Group I

EXPERIMENTAL

Patients will receive norepinephrine \<0.15 µg/kg/minute

Drug: Group I: Patients will receive norepinephrine <0.15 µg/kg/min

Group II

EXPERIMENTAL

Patients will receive norepinephrine ≥ 0.15 µg/kg/minutes

Drug: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min

Interventions

Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min DRUG

Patients will receive norepinephrine ≥ 0.15 µg/kg/min

Group II

Group I: Patients will receive norepinephrine <0.15 µg/kg/min DRUG

Patients will receive norepinephrine \<0.15 µg/kg/min

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: October 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)