| CTRI Number |
CTRI/2025/11/098179 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pulse Pressure as a Bedside Tool to Monitor Stroke Volume in Critical Illness |
|
Scientific Title of Study
|
Can Pulse Pressure Assessment At The Bedside Detect Low Values Or Track Changes Of Stroke Volume In Critically lll Patients? The ANDROMEDA-
PEGASUS Study |
| Trial Acronym |
ANDROMEDA-PEGASUS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06737614 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ripenmeet Salhotra |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research center Faridabad |
| Address |
Department of Anesthesiology and Critical Care
Amrita hospital sector 88 Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9810390927 |
| Fax |
|
| Email |
rippan.salhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ripenmeet Salhotra |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research center Faridabad |
| Address |
Department of Anesthesiology and Critical Care
Amrita hospital sector 88 Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9810390927 |
| Fax |
|
| Email |
rippan.salhotra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ripenmeet Salhotra |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research center Faridabad |
| Address |
Department of Anesthesiology and Critical Care
Amrita hospital sector 88 Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9810390927 |
| Fax |
|
| Email |
rippan.salhotra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre Faridabad 121002 |
|
|
Primary Sponsor
|
| Name |
Prof DAMPJ Gommers MD PhD |
| Address |
Erasmus MC, Doctor Molewaterplein 40 3015 GD Rotterdam, The Netherlands
31 10 704 0 704 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ripenmeet Salhotra Assistant Professor Critical Care Medicine |
Amrita Institute of Medical Sciences and Research Centre, Faridabad |
Medical ICU, 2nd floor,
Amrita Institute of Medical Sciences and Research Centre,
Sector 88, Near Delhi Mathura Road,
Faridabad 121001, Haryana, India
Faridabad
HARYANA |
9810390927
rippan.salhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee, Amrita Hospital Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R579||Shock, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
18 years and above of age
admitted to ICU
a functional Arterial line in place |
|
| ExclusionCriteria |
| Details |
pregnancy
inadequate arterial line transduction
refusal of consent
Patient who requires extracorporeal circulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictive capacity of pulse pressure (PP), measured via invasive arterial line, to detect low stroke volume (SV) as assessed by bedside echocardiography (LVOT-VTI) in critically ill patients. |
its a cross-sectional study, the observations and outcome (i.e the predictive capacity of Pulse pressure ) is determined at the same time point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictive capacity of pulse pressure to detect low stroke volume in subgroups (ARDS, postoperative states, septic shock, etc.) |
Single measurement during ICU stay |
| Influence of demographic, clinical, and technical factors (mechanical ventilation, vasoactive medication, age, arterial line site) on the predictive capacity of PP to estimate SV |
Single measurement during ICU stay |
| Ability of pulse pressure to track stroke volume changes during dynamic maneuvers (passive leg raise or fluid challenge) |
Before and after maneuver |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
|
This multicenter, cross-sectional, observational study aims to evaluate whether bedside pulse pressure assessment can reliably detect low stroke volume or track changes in stroke volume among critically ill adult patients. Pulse pressure, easily measured from routine arterial waveforms, may serve as a simple surrogate for stroke volume variation in resource-limited intensive care settings.
All participating ICUs will collect simultaneous hemodynamic data, including pulse pressure and reference stroke volume measurements obtained through validated methods such as echocardiography or advanced monitoring devices. The study will analyze the correlation between pulse pressure and stroke volume, assess the ability of pulse pressure to identify low stroke volume states, and explore factors affecting this relationship The study does not involve any intervention or alteration of clinical management. Results are expected to enhance understanding of simple, non-invasive hemodynamic indicators and support better bedside decision-making in the management of critically ill patients. |