Norepinephrine Equivalent Dose of Vasopressin, Phenylephrine and Epinephrine in Septic Shock

NCT06499467 | Recruiting

• 1 other identifier: 2024-112-DM-138
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Septic Shock

Keywords

Septic shock; Vasopressor Agent; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• 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

  Within 30 minutes of initiation of second vasopressor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients on mechanical ventilation who are in septic shock condition receiving norepinephrine as vasopressor

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

+91-522-249-5403; m.gurjar@rediffmail.com

Debanjan Bose, MD

CONTACT

debanjanbose1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 12, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

IN (1)