| CTRI Number |
CTRI/2025/08/092882 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of giving fluids guided by renal ultrasound on the kidney failure in patients with severe infections |
|
Scientific Title of Study
|
Effect of Renal Doppler based Hemodynamic Support titration on the incidence of Acute Kidney Injury in patients with Septic Shock: A Single Blinded Randomized Controlled 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 |
Deepak Singla |
| Designation |
AdditionalProfessor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepak Singla |
| Designation |
AdditionalProfessor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepak Singla |
| Designation |
AdditionalProfessor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Veerbhadra road, Rishikesh. 249203 |
| 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 Deepak Singla |
All India Institute of Medical Sciences |
Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh Dehradun UTTARANCHAL |
9068504999
deepak10.4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Renal doppler guided heamodynamic support |
Renal doppler based parameters will be used to guide the fluids and vasopressors |
| Comparator Agent |
Standard therapy group |
Standard parameters like inferior vena cava diameter, or pulse pressure variation will be used to guide the fluid and vasopressors |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients in septic shock |
|
| ExclusionCriteria |
| Details |
Refusal to consent.
Patients with preexisting acute kidney injury.
Patients with preexisting renal diseases such as unilateral kidney. renal stone disease, renal failure, renal artery stenosis.
Patient having any preexisting cardiopulmonary illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute kidney injury |
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PF Ratios |
Day 1, 3 and 7 |
| Lactate |
Day 1, 3 and 7 |
| Resolution of shock |
Within 7 days |
Length of ICU stay
|
till 28 days |
Length of hospital stay
|
till 28 days |
| Mortality |
till 28 days |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/10/2025 |
| 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="0" Months="0" 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
|
Septic shock is defined as a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Clinically, septic shock is identified by the need for vasopressor therapy to maintain a mean arterial pressure (MAP) of more than or equal to 65 mm Hg, along with a serum lactate level more than 2 mmol per L, despite adequate fluid resuscitation. Septic shock is a distributive shock which results from vasodilation and later damage to the microvascular endothelium resulting in capillary leakage and edema. So, exact titration of fluid becomes very important to maintain organ perfusion and to prevent the development of multi organ dysfunction syndrome (MODS). Organ systems affected in MODS include lungs resulting in acute respiratory distress syndrome (ARDS), kidney resulting in acute kidney injury (AKI), heart resulting in septic cardiomyopathy, brain resulting in septic encephalopathy and so on. Among these complications, AKI is one of the most common, affecting nearly 50 percent of patients in intensive care units. According to the KDIGO (Kidney Disease: Improving Global Outcomes) 2012 Clinical Practice Guidelines, acute kidney injury (AKI) is defined as any of the following: An increase in serum creatinine by more than or equal to 0.3 mg per dL within 48 hours, or an increase in serum creatinine to more than or equal to 1.5 times baseline, known or presumed to have occurred within the prior 7 days, or a urine output less than 0.5 mL per kg per h for 6 hours. Septic shock patients have developed AKI even with proper monitoring of parameters such as mean arterial pressure, central venous pressure, and lactate. The pathophysiology of AKI is due to variation in perfusion due to hemodynamic instability, excessive venous congestion, inflammation, and cytokine induced circulatory damage. These commonly used methods of monitoring fluid responsiveness have less sensitivity in predicting MODS, as none of these can quantify perfusion at organ level, further necessitating the need for newer indices. Hence the new techniques such as renal doppler have been evaluated to predict the risk of AKI in patients with sepsis. |
|