| CTRI Number |
CTRI/2025/03/082235 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To see recovery in patients with sepsis and low blood pressure using different measures of blood flow. |
|
Scientific Title of Study
|
Evaluating prognosis in septic shock patient using various perfusion markers during resuscitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ekta Tiwari |
| Designation |
DrNB SS Resident |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi
South
DELHI
110025
India |
| Phone |
8383029224 |
| Fax |
|
| Email |
etiwari05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Ray |
| Designation |
Senior Consultant and Head of Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
New Delhi
Holy Family Hospital
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Ray |
| Designation |
Senior Consultant and Head of Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
New Delhi
Holy Family Hospital
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Holy Family Hospital
Okhla Road
New Delhi-110025
India
New Delhi-110025
India |
|
|
Primary Sponsor
|
| Name |
Dr Ekta Tiwari |
| Address |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi-110025
India |
| 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 Ekta Tiwari |
Holy Family Hospital |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi-110025
India
South
DELHI |
8383029224
research2024.ccm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Holy Family Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients more than 18 years of age admitted in ICU with sepsis shock.
2.Patient presenting with septic shock. (According to sepsis-3 definition, Septic shock is defined as persistent hypotension despite adequate fluid resuscitation and need for vasopressor requirement to target mean arterial pressure (MAP) more than or equal to 65mmhg more than 2 mmol per L blood lactate levels and as per dynamic fluid resuscitation.
3.Patients in those central line can be inserted |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2.Pregnancy & lactating women
3.Patient with congestive heart failure
4.Patient with active bleed
5.Patient refusing for consent for enrolment in the study
6.Inability to insert central insertion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation between the three perfusion markers (lactate level, capillary refill time & P(c-va) co2 gradient) in hospital |
0, 3, 6, 12, 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In hospital mortality |
30 days |
| Organ Failure |
1st, 3rd day |
| Vasopressor dose & duration |
At discharge |
| Fluid requirements |
12hr, 24 hrs |
| Need of Invasive mechanical ventilation & duration of mechanical ventilation in days. |
At discharge |
| Need for RRT & number of days on RRT (Renal Replacement Therapy) |
At discharge |
| Cumulative fluid balance |
Day1, Day3 |
| ICU & Hospital Length of Stay |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective, observational study will be conducted in the critical care department at Holy Family Hospital, New Delhi, focusing on patients over 18 years of age with septic shock admitted to the ICU. The study will follow the Surviving Sepsis Campaign (SSC) 2021 guidelines for managing septic shock, including optimizing preload with fluid resuscitation and vasopressor infusion to maintain a MAP greater than or equal to 65 mmHg. Various dynamic resuscitation measures, such as pulse pressure variation, inferior Vena cava assessment, and mini fluid challenge, will guide fluid therapy. Safety indicators, such as clinical judgement and lung ultrasound findings, will be used to adjust fluid and vasopressor therapy. A multimodal perfusion assessment will be performed at baseline and at multiple time points (3,6,12 and 24 hours) after resuscitation, including macro-hemodynamic variables, lactate clearance, and peripheral perfusion assessment via capillary refill time. All patients will be followed up until discharge or for 30 days, collecting data on demographics, sepsis sources, management, and clinical parameters for analysis. |