NCT03475667

Brief Summary

Inaccurate monitoring of mean arterial pressure (MAP) could lead to improper treatment in the form of excessive fluid infusion or unnecessary vasopressor therapy; therefore, accurate hemodynamic monitoring is crucial in treatment of septic shock. In critically ill septic patients treated with vasoactive drugs, many studies reported that radial arterial pressure monitoring significantly underestimates central arterial pressure. Insertion of a femoral line allowed a substantial reduction of the infusion rate of vasoactive drugs in these patients. These findings might imply that femoral placement of arterial lines is the gold standard for invasive arterial blood pressure monitoring in shock patient. Our study aimed to determine the difference between radial (peripheral) and femoral (central) arterial pressures measured simultaneously in a group of critically ill patients receiving high dose noradrenaline therapy (≥ 0.1 mcg/kg/min).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

March 18, 2018

Last Update Submit

February 12, 2023

Conditions

Keywords

Septic Shockhemodynamic monitoringblood pressure determination

Outcome Measures

Primary Outcomes (1)

  • To compare radial and femoral arterial invasive blood pressure measurements in patients receiving high dose of noradrenaline (≥ 0.1 mcg/kg/min).

    Comparison of radial and femoral artery site invasive blood pressure measurement in septic patients on high dose of noradrenaline

    Within 5 minutes of placement of femoral artery catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients having septic shock on high dose of noradrenaline (≥0.1 mcg/kg/min) for at least 30 minutes.

You may qualify if:

  • All ICU patients who are ≥18 years with septic shock on high dose of noradrenaline (≥0.1 mcg/kg/min) for at least 30 minutes

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • Patient who cannot be made supine as per clinical condition
  • Patients having abdominal compartment syndrome
  • Known peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (1)

  • Bhaskar B, Gurjar M, Mishra P, Azim A, Poddar B, Baronia AK. Arterial site selection for measurement of mean arterial pressure in septic shock patients on high-dose norepinephrine. Front Med (Lausanne). 2022 Dec 23;9:1019752. doi: 10.3389/fmed.2022.1019752. eCollection 2022.

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Mohan Gurjar, MD, PDCC

    Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 23, 2018

Study Start

April 11, 2018

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations