| CTRI Number |
CTRI/2025/09/094573 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between Mean perfusion pressure and Acute kidney injury in Septic Shock: A Cohort Study |
|
Scientific Title of Study
|
Association between Mean perfusion pressure and Acute kidney injury in Septic Shock: A Cohort Study |
| 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. Kaushik D S |
| Designation |
Senior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi
Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7019847707 |
| Fax |
|
| Email |
kaushikshetty1214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sulagna Bhattacharjee |
| Designation |
Ascociate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik D S |
| Designation |
Senior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7019847707 |
| Fax |
|
| Email |
kaushikshetty1214@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Kaushik D S |
AIIMS New Delhi |
AB8ICU, Dept of Anaesthesiology Critical Care and Pain Medicine
AIIMS, New Delhi
New Delhi
DELHI |
7019847707
kaushikshetty1214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute Ethics Committee for Post Graduate ResearchAIIMS new Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18-75 years admitted to ICU with sepsis as per Sepsis-3 criteria and shock |
|
| ExclusionCriteria |
| Details |
Patient refusal to enroll to the study
Pregnant patients
Patients who are already a known case of CKD stage 3 and above
Patient diagnosed with AKI stage 3 as per KDIGO criteria
Patients with raised intra-abdominal pressure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of AKI will be measured by Serum Creatinine levels and urine output as per KDIGO criteria for AKI |
Hospital discharge or day 30 whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The trajectory of mean perfusion pressure with daily SOFA scores |
day 3 |
| Association of MPP trajectory with mortality |
day 30 |
| Association between trajectories of MPP & AKI |
day 3 |
| Association between MPP & RRT free days |
day 30 |
| Association between MPP & lactate clearance during |
72hrs |
| Association between MPP & cumulative fluid balance |
day 3 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/09/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be a prospective single- centre cohort study. The study will be carried out in ICUs of AIIMS New Delhi between August 2025- May 2027. The patients fulfilling inclusion and exclusion criteria will be recruited to the study. All the patients diagnosed to have sepsis with septic shock as per Sepsis-324 criteria will receive initial resuscitation as per Surviving Sepsis Campaign Guidelines with crystalloids 30ml/kg. If Mean Arterial Pressure (MAP) is less than 65mmHg, vasopressors are added as per SSC guidelines.21 All the patients will have an invasive arterial line for continuous invasive arterial blood pressure monitoring and a central venous catheter, continuous Central Venous Pressure is monitored. Rest of the management will be as per the treating physician’s decision.At the admission to the ICU, demographic data like age, sex comorbidities will be collected Charlson comorbidity index will be calculated. Baseline Serum Creatinine, CVP, MAP and dose of vasopressors and inotropes are noted and Vasoactive inotrope score(VIS) will be calculated. Time to enrolment from diagnosis of sepsis will be noted. SOFA score and APACHE II scores will be calculated. During the ICU stay mean arterial pressure and central venous pressure will be noted every 6th hourly for the first 3 days. Hourly urine output will be noted. Ventilatory parameters like peak pressure, tidal volume, respiratory rate will be noted. Daily serum creatinine levels will be measured. Cumulative fluid balance and lactate levels will be noted for the first 3 days. Daily SOFA scores will be noted. Point of care ultrasound(POCUS) findings and intraabdominal pressure will be noted if available. Occurrence of AKI will be measured by Serum Creatinine levels and urine output as per KDIGO criteria for AKI 1. Other outcomes like duration of mechanical ventilation, length of ICU stay, requirement of RRT and ICU mortality are noted. |