Observational Study About the Use of Perfusion Index to Use Vasopressor in Sepsis

NCT06860438 | Recruiting

• 1 other identifier: FMASU MD12/2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this thesis we will use the current state of knowledge that PI can provide a reliable information about the state of peripheral microcirculation during the state of sepsis and septic shock in ICU patients and that can interfere with the timing of starting vasopressor treatment in sepsis and septic shock

Conditions

Sepsis; Perfusion Index; Vasopressor

Outcome Measures

Primary Outcomes (1)

• PI (perfusion index ) variable will be measured at the start of resuscitation and at the start of vasopressor therapy

  PI will be measured at the start of resuscitation after volume resuscitation and before the use of vasopressor then will be measured 6 hours after resuscitation

  PI variable will be recorded at baseline( T0 )and after 5 minutes from starting of resuscitation (T5) and then 6 hours thereafter for 24 hours

Secondary Outcomes (8)

• Mean arterial Blood pressure

  Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours

• Heart rate (HR)

  Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours

• The central venous-arterial blood carbon dioxide partial pressure difference (Pv-aCO2)

  Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours

• arterial lactate concentration

  Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours

• ScvO2 (central venous oxygen saturation )

  Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours

Study Arms (2)

vasopressor

Drug: Vasoconstrictor Agents

no vasopressor

Interventions

Vasoconstrictor Agents DRUG

vasopressor agents will be started in patients with sepsis who will not improved using the resuscitation fluids

vasopressor

Eligibility Criteria

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

Study Population

ICU patients with sepsis

You may qualify if:

• \- All ICU patients with clinically suspected sepsis and septic shock ( signs include fever hypotension oliguria and confusion combined with culture results showing infection .Septic shock is a subset of sepsis involves persistent hypotension (mean arterial pressure ≥ 65 mm Hg, and a serum lactate level \> 18 mg/dL \[2 mmol/L)not responding to fluid resuscitation ) .

You may not qualify if:

• Pregnant females
• Patients on vasopressor or positive inotropic drugs
• Patients with hypothermia (defined as central temperature \<35°C).
• Patient with impairment of upper extremity circulation,(such as those who underwent radial artery harvesting for coronary artery bypass grafting or had suspected occlusion of the radial artery prior to surgery,)
• Patients had undergone an operation that involved the large arteries of the aortic arch.
• Patients with atherosclerosis .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of medicine Ain Shams University

Cairo, 11757, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Nancy shaker ass,lecurer

  faculty of medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Shaker ass.lecturer

CONTACT

00201067003436; nancy.shaker@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 6, 2025
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)