| CTRI Number |
CTRI/2026/01/101120 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Two Methods of Stopping Blood Pressure Support Medicines in Patients with Septic Shock |
|
Scientific Title of Study
|
Comparative analysis of vasopressor weaning strategies in
Septic shock evaluating the clinical outcomes of
Noradrenaline first vs vasopressin first approaches
A randomised control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Ray Mohapatra |
| Designation |
Clinical tutor |
| Affiliation |
Armed forces medical college |
| Address |
1st floor department of anaesthesiology Armed forces medical college
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7276632896 |
| Fax |
|
| Email |
araymohapatra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akash Ray Mohapatra |
| Designation |
Clinical tutor |
| Affiliation |
Armed forces medical college |
| Address |
1st floor department of anaesthesiology Armed forces medical college
Wanowarie Pune- 411040
MAHARASHTRA
411040
India |
| Phone |
7276632896 |
| Fax |
|
| Email |
araymohapatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Ray Mohapatra |
| Designation |
Clinical tutor |
| Affiliation |
Armed forces medical college |
| Address |
1st floor department of anaesthesiology Armed forces medical college
Wanowarie Pune- 411040
MAHARASHTRA
411040
India |
| Phone |
7276632896 |
| Fax |
|
| Email |
araymohapatra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Somya Sharma |
| Address |
Department of Anaesthesia
Armed forces medical college
Pune 411040 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Ray Mohapatra |
Armed forces medical college |
1st floor department of anesthesiology
Armed forces medical college
pune
Pune
MAHARASHTRA |
7276632896
araymohapatra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Vasopressin discontinued first, followed by norepinephrine.
|
Baseline data will be collected before the discontinuation of any vasopressor, including
demographic information (age, sex, weight, primary diagnosis), comorbidities (such as
diabetes, hypertension, chronic kidney disease), severity scores (SOFA and APACHE II),
source of sepsis (pulmonary, urinary, abdominal, etc.), vasopressor doses (norepinephrine and
vasopressin), hemodynamic parameters (mean arterial pressure, heart rate, respiratory rate),
and lab values (lactate levels, creatinine, urine output if available). Our standard practice of care
in ICU is discontinuation of vasopressin first followed by noradrenaline which will be the control
arm for the study. The sequence of vasopressor discontinuation will be recorded, with patients
assigned to either Group A, where vasopressin is discontinued first route IV DOSE 1U PER HOUR DURATION MAP TARGET MORE THAN 65 MM HG |
| Comparator Agent |
Group B: Norepinephrine discontinued first, followed by vasopressin.
|
Group B where norepinephrine is discontinued first This process will be monitored but it will not be influenced by the study team Monitoring begins at the moment of discontinuation of the first vasopressor After the first vasopressor is discontinued hemodynamic parameters such as MAP heart rate respiratory rate and SpO2 will be measured at multiple time points just before discontinuation T0 one hour after discontinuation T1 three hours T3 and six hours T6 ROUTE IV DOSE 0.1 MCG PER KG PER HOUR DURATION MAP TARGET MORE THAN 65 MM HG
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (more than or equal to 18 years) admitted to the ICU with a diagnosis of septic shock based on
Sepsis-3 criteria.
Treated with both norepinephrine and vasopressin for at least 12 hours.
Achieved hemodynamic stability (MAP more than or equal to 65 mmHg) with stable or decreasing vasopressor
requirements.
All patients on invasive hemodynamic monitoring. |
|
| ExclusionCriteria |
| Details |
Patients or legally authorized representative refusing consent
Use of additional vasopressors for example epinephrine dopamine
Hemodynamic instability requiring escalation at the time of weaning
Severe cardiac arrhythmias including ventricular fibrillation ventricular tachycardia paroxysmal supraventricular tachycardia second degree heart block third degree heart block complete heart block atrial fibrillation causing instability
Cardiogenic shock
Advanced liver failure
Left ventricular ejection fraction less than 45 percent on bedside echocardiography
Pregnant or lactating women
Any patient or their legally authorized representative who withdraws consent at any time during the conduct of the study will not be included in the study
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of hypotension following the discontinuation of norepinephrine first
versus vasopressin first in adult patients recovering from septic shock. |
After the first vasopressor is discontinued hemodynamic parameters such as MAP heart rate respiratory rate and SpO2 will be measured at multiple time points just before discontinuation T0 one hour after discontinuation T1 three hours T3 and six hours T6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the need for re initiation or escalation of vasopressor therapy post discontinuation
To compare incidence of acute kidney injury in both groups post discontinuation
To compare the intensive care unit length of stay between patients in the two discontinuation arms
|
After the first vasopressor is discontinued hemodynamic parameters such as MAP heart rate respiratory rate and SpO2 will be measured at multiple time points just before discontinuation T0 one hour after discontinuation T1 three hours T3 and six hours T6
|
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Septic shock is a severe and life threatening form of sepsis marked by major disturbances in circulation cellular function and metabolism leading to high mortality. It is commonly defined by persistent low blood pressure requiring vasopressor support to maintain adequate mean arterial pressure along with elevated serum lactate levels despite proper fluid resuscitation. Even with improvements in intensive care practices septic shock continues to carry high rates of illness and death worldwide. A key aspect of septic shock management is the use of vasopressors to support blood pressure and organ perfusion. Noradrenaline and vasopressin are commonly used agents. Noradrenaline is widely accepted as the first line vasopressor because it effectively increases vascular tone with a relatively lower risk of heart rhythm disturbances. Vasopressin works through a different mechanism and is usually added when blood pressure remains low despite adequate doses of noradrenaline. While initiation of vasopressors is well studied the best method for reducing and stopping these drugs once the patient stabilizes remains unclear. In routine practice the order of vasopressor withdrawal often depends on clinician preference rather than strong evidence. Some studies suggest that the sequence of discontinuation may affect blood pressure stability need for restarting vasopressors length of intensive care stay and overall outcomes. Stopping a vasopressor too early may cause instability while prolonged use may increase the risk of side effects related to each drug. Noradrenaline has a short duration of action and can be adjusted easily whereas vasopressin has a longer lasting effect and is usually given at a fixed dose. These differences suggest that the order of weaning may influence patient recovery. However high quality randomized trials comparing these strategies are limited. This study aims to compare noradrenaline first versus vasopressin first weaning strategies in patients with septic shock receiving both agents. By evaluating outcomes such as blood pressure stability need for restarting vasopressors intensive care stay and mortality this trial seeks to provide evidence to guide clinical decision making and improve care for patients with septic shock. |