Septic ShockNCT06499467
Norepinephrine Equivalent Dose of Vasopressin, Phenylephrine and Epinephrine in Septic Shock
An observational study of Septic Shock, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial summary
Septic shock is the most common form of circulatory shock encountered in patients admitted in intensive care unit. The initial management involves fluid resuscitation but if hypotension does not get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jul 2024to 30 Jan 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients on mechanical ventilation who are in septic shock condition receiving norepinephrine as vasopressor
Who may be able to join
- All adult patients on mechanical ventilation in septic shock receiving norepinephrine in whom the treating clinical team plan to add another vasopressor, will be considered for inclusion if they meet these two condition (1) Patient is on Norepinephrine infusion at least 0.1 mcg/kg/min for the last 6 hours; and (2) There has been no dose alteration in the infusion of norepinephrine for the last 2 hours
Who cannot join
- There are concurrently other forms of shock like cardiogenic, obstructive, anaphylactic or hypovolemic.
- The patient has arrhythmias during the current course of illness.
- The patient has asynchrony on mechanical ventilator despite airway clearance with suctioning and adequate sedation at the time of study measurement.
- The patient is hypovolemic with ongoing fluid resuscitation in the form of fluid boluses, blood or blood product transfusions at the time of study measurement.
- The patient receives diuretic boluses or undergoes hemodialysis sessions at the time of study measurement.
- Pregnancy
- Patient who didn't consent for study or withdrew the consent at any point of the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Norepinephrine Equivalent Dose of Vasopressin, Phenylephrine and Epinephrine in Septic Shock Patients: A Prospective Study
Septic shock is the most common form of circulatory shock encountered in patients admitted in intensive care unit. The initial management involves fluid resuscitation but if hypotension does not get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean arterial pressure (MAP).
Norepinephrine is recommended as the first line vasopressor in the management of septic shock as per Surviving Sepsis Campaign guidelines of 2021. It recommends addition of vasopressin to the regime if the target MAP is not achieved with just norepinephrine. However, in clinical practice various other vasopressors are being used in the management of septic shock, as per clinical condition. Different vasopressors have different modes of action and pharmacological effects on hemodynamics. Therefore, there evolved the need of development of a formula that would reflect the potency of each vasopressor in a standardized manner. Thus, the concept of Norepinephrine Equivalence (NEE) came into existence. In the recent years, different studies were conducted in various parts of the world with different primary objectives. These authors have proposed different formulas for calculation Norepinephrine Equivalence (NEE) dose of the used vasopressors as an inference from their studies. All these formulas are based on assumptions and there lacks standardization. There are presently no studies available in the existing literature, where a prospective study is done to primarily determine the Norepinephrine equivalence dose (NEE) of other vasopressors in patients of septic shock. Hence, the investigators aim to find out equivalent dose of these different drugs, which are being used commonly in the management of septic shock, in a prospective planned study.
Read the detailed description
Sepsis is a life-threatening state of organ dysfunction caused by dysregulated response of host to infection. It is the most common form of circulatory shock encountered in patients admitted in intensive care unit. In physiological state, blood pressure is maintained by the interplay of three major mechanisms namely sympathetic nervous system, vasopressin system and renin aldosterone system. However in the states of vasodilatory shock, these homeostatic mechanisms are disturbed. The initial management involves fluid resuscitation but if hypotension doesn't get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean arterial pressure (MAP).
Norepinephrine has been recommended as the first line vasopressor for management of septic shock since 2004 and the latest guideline recommends addition of vasopressin along with norepinephrine when the target MAP is not achieved. However, in clinical practice various other vasopressors are used in the management of septic shock. Different vasopressors have different modes of action and pharmacological effects on hemodynamics. Therefore, there evolved the need of development of a formula that would reflect the potency of each vasopressor in a standardized manner. Thus, the concept of Norepinephrine Equivalence (NEE) came into existence. It is a scale to quantify the exposure to various vasopressors, by converting their dose as an equivalent of norepinephrine. It allows us to combine the dose of other vasopressors in a single scale and quantitatively assess the severity of shock when norepinephrine is being used along with other vasopressors.
Annane et al conducted a study in 2007 in 330 patients of septic shock with the primary objective of comparing the efficacy and safety of norepinephrine plus dobutamine with those of epinephrine alone in septic shock. They inferred from their study that the doses of vasopressors needed to achieve the MAP target were same for epinephrine and norepinephrine. Similarly, Myburgh et al studied in 280 patients of circulatory shock in the year 2008 to determine whether there was any difference between epinephrine and norepinephrine in achievement of MAP goal in the ICU patients and found that the maximal daily infusion of epinephrine and norepinephrine didn't have difference to achieve a target MAP. De Becker et al conducted a study in 2003 on 20 septic shock patients with the primary objective to assess the effects of different doses of dopamine, norepinephrine and epinephrine on the splanchnic circulation in patients of septic shock. They found that the final infusion rate of epinephrine was 0.62 mcg/kg/min, which was comparable to 0.45 mcg/kg/min rate of norepinephrine infusion to achieve the target MAP, suggesting a conversion ratio of 1.4:1. Hussain et al found in their study on 42 patients of septic shock in 2014 to determine the efficacy of phenylephrine in comparison to norepinephrine in patients of septic shock in ICU, that phenylephrine was 1.1 times equipotent to norepinephrine. Gordon et al studied on 409 patients of septic shock in 2016 to compare the effect of early vasopressin versus norepinephrine on kidney failure. They concluded from their study that 0.04U/min of vasopressin to be equivalent to 0.1 mcg/kg/min of norepinephrine.
Goradia et al proposed a norepinephrine equivalent formula in 2021 in their review article as Norepinephrine dose (mcg/kg/min) + epinephrine dose (mcg/kg/min) + 2.5 x vasopressin (U/min) + 0.1 × phenylephrine dose (mcg/kg/min). Kotani et al proposed a different norepinephrine equivalent formula in 2023 as follows Norepinephrine dose (µg/kg/min) + epinephrine dose (µg/kg/ min) + 0.06 × phenylephrine dose (µg/kg/min) + 2.5 × vasopressin dose (U/min).
However, since these calculations of NEE are based on assumptions and not standardized, there are several different formulae for calculation of the same. Different studies were conducted in different parts of the world with different primary objectives, the authors proposed different NEE formulas of the used vasopressor as an inference from their studies.
Presently, there are no studies available in the existing literature where a prospective study is done to primarily determine the Norepinephrine equivalence of other vasopressors namely vasopressin, phenylephrine and epinephrine, in patients of septic shock. Hence, the investigators aimed to study the NEE dose of the commonly used vasopressors in the ICU in septic shock patients.
During the study period, all adult ICU patients having septic shock will be considered for inclusion. Once the patient meets the inclusion/exclusion criteria, informed written consent will be obtained at the beginning of the study. The weight of the patient will be noted from the weight-measuring beds and the drug preparations are made accordingly. The transducer will be zeroed to the atmospheric pressure and baseline MAP will be recorded. A second vasopressor will be connected to the central venous catheter (CVC) as per the standard preparation. Then Norepinephrine infusion dose will be deescalated over 5-10 minutes by 0.1 mcg/kg/min. Simultaneously, the dose of the second vasopressor will be titrated to achieve the baseline MAP (±1 mmHg). Two readings of the dose of the second vasopressor will be recorded at least 5 minutes apart and their mean will be calculated. Evaluation with more than one vasopressor will depend upon the clinical condition of the patient as decided by the treating team. However, if more than one vasopressor are being assessed for NEE dose, then the next drug will be assessed after at least one hour gap. The same patient can be included for the study for more than once if they receive norepinephrine in three different dose ranges viz 0.1-0.5 mcg/kg/min, 0.5-1 mcg/kg/min and >1 mcg/kg/min.
Demographic and clinical characteristics of included patients will be recorded in structured case report forms. Candidates who qualify for the inclusion criteria will be included in the study. The baseline MAP will be recorded. The norepinephrine infusion will be tapered down gradually by 0.1 mcg/kg/min and in the meanwhile a second vasopressor will be introduced to maintain the baseline MAP recorded at the beginning of the study. After 15 minutes of stabilization of the dose of the second vasopressor, two readings of the dose of the second vasopressor will be taken 5 minutes apart and their mean will be taken as a NEE of that particular vasopressor.
- Conditions
- Septic Shock
- Keywords
- Septic shock, Vasopressor Agent, Norepinephrine
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the norepinephrine equivalent dose of vasopressin, phenylephrine and epinephrine used in patients of septic shock.
Norepinephrine will be gradually tapered by 0.1 mcg/kg/min over 10-15 minutes and simultaneously a second vasopressor will be introduced to maintain the baseline MAP (± 1 mm Hg). After stabilization for at least 5 minutes and achieving the same baseline MAP, two readings of the dose of the second vasopressor will be recorded, at least 5 min apart, and averaged. The averaged value of the second vasopressor dose will be considered as a NEE dose for that particular vasopressor against NE dose of 0.1 mcg/kg/min
Measured: Within 30 minutes of initiation of second vasopressor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start12 Jul 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 120 participants (actual)
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
- NCT06499467
- Sponsor's protocol ID
- 2024-112-DM-138
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Equivalent Dose of Vasopressin, Phenylephrine and Epinephrine in Septic Shock Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT06499467
- Acronym / sponsor ID
- 2024-112-DM-138
- Conditions
- Septic Shock
- Keywords
- Septic shock, Vasopressor Agent, Norepinephrine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 12 Jul 2024 (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.
Septic shock is the most common form of circulatory shock encountered in patients admitted in intensive care unit. The initial management involves fluid resuscitation but if hypotension does not get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean arterial pressure (MAP).
Norepinephrine is recommended as the first line vasopressor in the management of septic shock as per Surviving Sepsis Campaign guidelines of 2021. It recommends addition of vasopressin to the regime if the target MAP is not achieved with just norepinephrine. However, in clinical practice various other vasopressors are being used in the management of septic shock, as per clinical condition. Different vasopressors have different modes of action and pharmacological effects on hemodynamics. Therefore, there evolved the need of development of a formula that would reflect the potency of each vasopressor in a standardized manner. Thus, the concept of Norepinephrine Equivalence (NEE) came into existence. In the recent years, different studies were conducted in various parts of the world with different primary objectives. These authors have proposed different formulas for calculation Norepinephrine Equivalence (NEE) dose of the used vasopressors as an inference from their studies. All these formulas are based on assumptions and there lacks standardization. There are presently no studies available in the existing literature, where a prospective study is done to primarily determine the Norepinephrine equivalence dose (NEE) of other vasopressors in patients of septic shock. Hence, the investigators aim to find out equivalent dose of these different drugs, which are being used commonly in the management of septic shock, in a prospective planned study.
Detailed description
Sepsis is a life-threatening state of organ dysfunction caused by dysregulated response of host to infection. It is the most common form of circulatory shock encountered in patients admitted in intensive care unit. In physiological state, blood pressure is maintained by the interplay of three major mechanisms namely sympathetic nervous system, vasopressin system and renin aldosterone system. However in the states of vasodilatory shock, these homeostatic mechanisms are disturbed. The initial management involves fluid resuscitation but if hypotension doesn't get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean arterial pressure (MAP).
Norepinephrine has been recommended as the first line vasopressor for management of septic shock since 2004 and the latest guideline recommends addition of vasopressin along with norepinephrine when the target MAP is not achieved. However, in clinical practice various other vasopressors are used in the management of septic shock. Different vasopressors have different modes of action and pharmacological effects on hemodynamics. Therefore, there evolved the need of development of a formula that would reflect the potency of each vasopressor in a standardized manner. Thus, the concept of Norepinephrine Equivalence (NEE) came into existence. It is a scale to quantify the exposure to various vasopressors, by converting their dose as an equivalent of norepinephrine. It allows us to combine the dose of other vasopressors in a single scale and quantitatively assess the severity of shock when norepinephrine is being used along with other vasopressors.
Annane et al conducted a study in 2007 in 330 patients of septic shock with the primary objective of comparing the efficacy and safety of norepinephrine plus dobutamine with those of epinephrine alone in septic shock. They inferred from their study that the doses of vasopressors needed to achieve the MAP target were same for epinephrine and norepinephrine. Similarly, Myburgh et al studied in 280 patients of circulatory shock in the year 2008 to determine whether there was any difference between epinephrine and norepinephrine in achievement of MAP goal in the ICU patients and found that the maximal daily infusion of epinephrine and norepinephrine didn't have difference to achieve a target MAP. De Becker et al conducted a study in 2003 on 20 septic shock patients with the primary objective to assess the effects of different doses of dopamine, norepinephrine and epinephrine on the splanchnic circulation in patients of septic shock. They found that the final infusion rate of epinephrine was 0.62 mcg/kg/min, which was comparable to 0.45 mcg/kg/min rate of norepinephrine infusion to achieve the target MAP, suggesting a conversion ratio of 1.4:1. Hussain et al found in their study on 42 patients of septic shock in 2014 to determine the efficacy of phenylephrine in comparison to norepinephrine in patients of septic shock in ICU, that phenylephrine was 1.1 times equipotent to norepinephrine. Gordon et al studied on 409 patients of septic shock in 2016 to compare the effect of early vasopressin versus norepinephrine on kidney failure. They concluded from their study that 0.04U/min of vasopressin to be equivalent to 0.1 mcg/kg/min of norepinephrine.
Goradia et al proposed a norepinephrine equivalent formula in 2021 in their review article as Norepinephrine dose (mcg/kg/min) + epinephrine dose (mcg/kg/min) + 2.5 x vasopressin (U/min) + 0.1 × phenylephrine dose (mcg/kg/min). Kotani et al proposed a different norepinephrine equivalent formula in 2023 as follows Norepinephrine dose (µg/kg/min) + epinephrine dose (µg/kg/ min) + 0.06 × phenylephrine dose (µg/kg/min) + 2.5 × vasopressin dose (U/min).
However, since these calculations of NEE are based on assumptions and not standardized, there are several different formulae for calculation of the same. Different studies were conducted in different parts of the world with different primary objectives, the authors proposed different NEE formulas of the used vasopressor as an inference from their studies.
Presently, there are no studies available in the existing literature where a prospective study is done to primarily determine the Norepinephrine equivalence of other vasopressors namely vasopressin, phenylephrine and epinephrine, in patients of septic shock. Hence, the investigators aimed to study the NEE dose of the commonly used vasopressors in the ICU in septic shock patients.
During the study period, all adult ICU patients having septic shock will be considered for inclusion. Once the patient meets the inclusion/exclusion criteria, informed written consent will be obtained at the beginning of the study. The weight of the patient will be noted from the weight-measuring beds and the drug preparations are made accordingly. The transducer will be zeroed to the atmospheric pressure and baseline MAP will be recorded. A second vasopressor will be connected to the central venous catheter (CVC) as per the standard preparation. Then Norepinephrine infusion dose will be deescalated over 5-10 minutes by 0.1 mcg/kg/min. Simultaneously, the dose of the second vasopressor will be titrated to achieve the baseline MAP (±1 mmHg). Two readings of the dose of the second vasopressor will be recorded at least 5 minutes apart and their mean will be calculated. Evaluation with more than one vasopressor will depend upon the clinical condition of the patient as decided by the treating team. However, if more than one vasopressor are being assessed for NEE dose, then the next drug will be assessed after at least one hour gap. The same patient can be included for the study for more than once if they receive norepinephrine in three different dose ranges viz 0.1-0.5 mcg/kg/min, 0.5-1 mcg/kg/min and >1 mcg/kg/min.
Demographic and clinical characteristics of included patients will be recorded in structured case report forms. Candidates who qualify for the inclusion criteria will be included in the study. The baseline MAP will be recorded. The norepinephrine infusion will be tapered down gradually by 0.1 mcg/kg/min and in the meanwhile a second vasopressor will be introduced to maintain the baseline MAP recorded at the beginning of the study. After 15 minutes of stabilization of the dose of the second vasopressor, two readings of the dose of the second vasopressor will be taken 5 minutes apart and their mean will be taken as a NEE of that particular vasopressor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients on mechanical ventilation who are in septic shock condition receiving norepinephrine as vasopressor
Key inclusion criteria (1 listed)
- All adult patients on mechanical ventilation in septic shock receiving norepinephrine in whom the treating clinical team plan to add another vasopressor, will be considered for inclusion if they meet these two condition (1) Patient is on Norepinephrine infusion at least 0.1 mcg/kg/min for the last 6 hours; and (2) There has been no dose alteration in the infusion of norepinephrine for the last 2 hours
Key exclusion criteria (7 listed)
- There are concurrently other forms of shock like cardiogenic, obstructive, anaphylactic or hypovolemic.
- The patient has arrhythmias during the current course of illness.
- The patient has asynchrony on mechanical ventilator despite airway clearance with suctioning and adequate sedation at the time of study measurement.
- The patient is hypovolemic with ongoing fluid resuscitation in the form of fluid boluses, blood or blood product transfusions at the time of study measurement.
- The patient receives diuretic boluses or undergoes hemodialysis sessions at the time of study measurement.
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 evaluate the norepinephrine equivalent dose of vasopressin, phenylephrine and epinephrine used in patients of septic shock.
Time frame: Within 30 minutes of initiation of second vasopressor
Norepinephrine will be gradually tapered by 0.1 mcg/kg/min over 10-15 minutes and simultaneously a second vasopressor will be introduced to maintain the baseline MAP (± 1 mm Hg). After stabilization for at least 5 minutes and achieving the same baseline MAP, two readings of the dose of the second vasopressor will be recorded, at least 5 min apart, and averaged. The averaged value of the second vasopressor dose will be considered as a NEE dose for that particular vasopressor against NE dose of 0.1 mcg/kg/min
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Sepsis
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 7 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 16 Oct 2026. 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 evaluate the norepinephrine equivalent dose of vasopressin, phenylephrine and epinephrine used in patients of septic shock. (time frame: Within 30 minutes of initiation of second vasopressor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.