Septic ShockNCT03475667
Comparison of Radial and Femoral Artery Site Invasive Blood Pressure Measurement in Septic Shock Patients
An observational study of Septic Shock, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 11 Apr 2018to 10 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients having septic shock on high dose of noradrenaline (≥0.1 mcg/kg/min) for at least 30 minutes.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Pregnancy
- Patient who cannot be made supine as per clinical condition
- Patients having abdominal compartment syndrome
- Known peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Critical Care Medicine, SGPGIMS
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Comparison of Radial and Femoral Artery Site Invasive Blood Pressure Measurement in Septic Patients on High Dose of Noradrenaline: A Prospective Observational Study
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).
Read the detailed description
Invasive arterial blood pressure monitoring is common in critically ill patients admitted in intensive care units (ICUs). The most common indication for invasive arterial blood pressure monitoring is for continuous measurement in hemodynamically unstable patients on vasopressor therapies Invasive arterial blood pressure monitoring is a standard of care during shock management in the ICU. The Surviving Sepsis Campaign international consensus guidelines (2016) recommend maintaining a mean arterial pressure (MAP) of 65 mmHg or greater, as a goal of initial resuscitation, and to apply vasopressors, if required, to maintain MAP at this level. The radial artery is most commonly used, with the femoral artery being the second choice; both site accounting as 92% of all arterial cannulations.
Accuracy of invasive blood pressure monitoring is crucial in evaluating the cardiocirculatory system and adjusting vasopressor therapy for hemodynamic support. However, the best site for catheter insertion is controversial. Compared with arterial pressure waveforms measured in the central arteries (eg, aorta or femoral artery), those at the periphery (eg, radial artery) characteristically have steeper upstrokes, higher systolic peaks, a later appearing diastolic notch, more prominent diastolic waves and lower end-diastolic pressure. Yet, under normal physiological conditions, only a negligible decrement in MAP occurs. In critically ill patients during aberrant hemodynamic conditions like septic shock, gradients in MAP may develop from the central to the peripheral arterial site.
There are some available studies where simultaneous measurement of radial and femoral was done in different patient population. In all studies where patients of cardiopulmonary bypass were included showed that there was significant difference in MAP and SBP between femoral and radial invasive blood pressure measurements with femoral site IBP being greater than radial site. Similar difference in SBP and MAP was noted in reperfusion stage of liver transplant patients. The difference was also found in septic shock patients in MAP with vasopressor usage but one study did not find significant difference in invasive MAP and SBP.
Work plan methodology:
This is a prospective observational study to know the difference in blood pressure recordings of invasive arterial BP (radial versus femoral site) in patients of septic shock on high dose of noradrenaline therapy (≥0.1 mcg/kg/min) for at least 30 minutes. Participant will be included from ICU of department of critical care medicine. All adult critically ill patients with septic shock requiring noradrenaline infusion (≥0.1 mcg/kg/min) will be considered for inclusion in this study. Participant will be included if treating team considered to change the site of arterial invasive blood pressure monitoring from radial to femoral site (same side, left or right).
All three measurements: systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MAP) will be recorded three times, simultaneously on the monitor within 5 minutes of placement of femoral arterial catheter by freezing/taking snapshot of the monitor. Measurement will be recorded in supine position, with radial arterial line transducer at the level of 5th rib in mid-axillary line. Femoral line transducer will be placed at the same level as radial line transducer; the equality of the levels of both the transducers will be confirmed with the help of spirit level technique. Investigators will use 20 gauge arterial cannula for radial artery cannulation and 16 gauge single lumen catheters for femoral artery cannulation with all aseptic precautions. Participant with any change in noradrenaline dose requirement during study period (measurement of pressures) will be excluded from the analysis
Sample size and statistical analysis:
From the previous observational study considering minimum average difference of mean MAP of 2.8 mm of Hg, investigators calculated the sample size with power analysis by using version 2008 (PASS-8). A sample size of 44 achieves 90% power to detect a mean of paired differences of 2.8 with an estimated standard deviation of differences of 5.6 and with a significance level (alpha) of 0.05 using a two-sided paired t-test. In this study, investigators would also like to do the subgroup analysis in patients on very high dose of noradrenaline (≥0.3 mcg/kg/min). So, investigators will include 80 patients. Mean of three recordings each of SBP, DBP and MBP will be calculated and appropriate statistical methods will be applied
Intervention:
None
Duration of the study:
21 months
- Conditions
- Septic Shock
- Keywords
- Septic Shock, hemodynamic monitoring, blood pressure determination
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 5 minutes of placement of femoral artery catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start11 Apr 2018
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Mohan Gurjar, MD, PDCC, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475667
- Sponsor's protocol ID
- 2018-27-DM-EXP
- Status last verified
- Feb 2023
- First submitted
- 18 Mar 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36619630
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radial and Femoral Artery Site Invasive Blood Pressure Measurement in Septic Patients on High Dose of Noradrenaline: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03475667
- Acronym / sponsor ID
- 2018-27-DM-EXP
- Conditions
- Septic Shock
- Keywords
- Septic Shock, hemodynamic monitoring, blood pressure determination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Invasive arterial blood pressure monitoring is common in critically ill patients admitted in intensive care units (ICUs). The most common indication for invasive arterial blood pressure monitoring is for continuous measurement in hemodynamically unstable patients on vasopressor therapies Invasive arterial blood pressure monitoring is a standard of care during shock management in the ICU. The Surviving Sepsis Campaign international consensus guidelines (2016) recommend maintaining a mean arterial pressure (MAP) of 65 mmHg or greater, as a goal of initial resuscitation, and to apply vasopressors, if required, to maintain MAP at this level. The radial artery is most commonly used, with the femoral artery being the second choice; both site accounting as 92% of all arterial cannulations.
Accuracy of invasive blood pressure monitoring is crucial in evaluating the cardiocirculatory system and adjusting vasopressor therapy for hemodynamic support. However, the best site for catheter insertion is controversial. Compared with arterial pressure waveforms measured in the central arteries (eg, aorta or femoral artery), those at the periphery (eg, radial artery) characteristically have steeper upstrokes, higher systolic peaks, a later appearing diastolic notch, more prominent diastolic waves and lower end-diastolic pressure. Yet, under normal physiological conditions, only a negligible decrement in MAP occurs. In critically ill patients during aberrant hemodynamic conditions like septic shock, gradients in MAP may develop from the central to the peripheral arterial site.
There are some available studies where simultaneous measurement of radial and femoral was done in different patient population. In all studies where patients of cardiopulmonary bypass were included showed that there was significant difference in MAP and SBP between femoral and radial invasive blood pressure measurements with femoral site IBP being greater than radial site. Similar difference in SBP and MAP was noted in reperfusion stage of liver transplant patients. The difference was also found in septic shock patients in MAP with vasopressor usage but one study did not find significant difference in invasive MAP and SBP.
Work plan methodology:
This is a prospective observational study to know the difference in blood pressure recordings of invasive arterial BP (radial versus femoral site) in patients of septic shock on high dose of noradrenaline therapy (≥0.1 mcg/kg/min) for at least 30 minutes. Participant will be included from ICU of department of critical care medicine. All adult critically ill patients with septic shock requiring noradrenaline infusion (≥0.1 mcg/kg/min) will be considered for inclusion in this study. Participant will be included if treating team considered to change the site of arterial invasive blood pressure monitoring from radial to femoral site (same side, left or right).
All three measurements: systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MAP) will be recorded three times, simultaneously on the monitor within 5 minutes of placement of femoral arterial catheter by freezing/taking snapshot of the monitor. Measurement will be recorded in supine position, with radial arterial line transducer at the level of 5th rib in mid-axillary line. Femoral line transducer will be placed at the same level as radial line transducer; the equality of the levels of both the transducers will be confirmed with the help of spirit level technique. Investigators will use 20 gauge arterial cannula for radial artery cannulation and 16 gauge single lumen catheters for femoral artery cannulation with all aseptic precautions. Participant with any change in noradrenaline dose requirement during study period (measurement of pressures) will be excluded from the analysis
Sample size and statistical analysis:
From the previous observational study considering minimum average difference of mean MAP of 2.8 mm of Hg, investigators calculated the sample size with power analysis by using version 2008 (PASS-8). A sample size of 44 achieves 90% power to detect a mean of paired differences of 2.8 with an estimated standard deviation of differences of 5.6 and with a significance level (alpha) of 0.05 using a two-sided paired t-test. In this study, investigators would also like to do the subgroup analysis in patients on very high dose of noradrenaline (≥0.3 mcg/kg/min). So, investigators will include 80 patients. Mean of three recordings each of SBP, DBP and MBP will be calculated and appropriate statistical methods will be applied
Intervention:
None
Duration of the study:
21 months
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients having septic shock on high dose of noradrenaline (≥0.1 mcg/kg/min) for at least 30 minutes.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Age <18 years
- Pregnancy
- Patient who cannot be made supine as per clinical condition
- Patients having abdominal compartment syndrome
- Known peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare radial and femoral arterial invasive blood pressure measurements in patients receiving high dose of noradrenaline (≥ 0.1 mcg/kg/min).
Time frame: Within 5 minutes of placement of femoral artery catheter
Comparison of radial and femoral artery site invasive blood pressure measurement in septic patients on high dose of noradrenaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Results publication: PubMed 36619630Bhaskar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Gurjar, MD, PDCC principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare radial and femoral arterial invasive blood pressure measurements in patients receiving high dose of noradrenaline (≥ 0.1 mcg/kg/min). (time frame: Within 5 minutes of placement of femoral artery catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.