| CTRI Number |
CTRI/2024/09/073205 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ACTIVE DE RESUSCITATION ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Active fluid in removal in patients with infection and organ failure |
|
Scientific Title of Study
|
Active bundle De Resuscitation in Septic shock : A 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 |
Dr. Sugumar M |
| Designation |
Senior Resident , Critical Care Medicine |
| Affiliation |
All India Institute of Medical Sciences , New Delhi |
| Address |
Department of Anaesthesiology, Teaching block 5th floor, Aiims, New Delhi, Ansari Nagar East, New Delhi
New Delhi DELHI 110049 India |
| Phone |
9626831200 |
| Fax |
|
| Email |
drsugumar2009@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Rahul Kumar Anand |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology , Teaching block 5th floor, AIIMS New Delhi, Ansari Nagar East, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9013082271 |
| Fax |
|
| Email |
drrahulkanand@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rahul Kumar Anand |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Teaching block 5th floor, Aiims, New Delhi, Ansari nagar East, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9013082271 |
| Fax |
|
| Email |
drrahulkanand@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Aiims, Ansari nagar Esat, New Delhi, 110029, India. |
| 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 SUGUMAR M |
Aiims |
Department of Anaesthesiology, Teaching block 5th floor New Delhi DELHI |
9626831200
drsugumar2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF ETHICS COMMITTEE AIIMS OT BLOCK ANSARI NAGAR, NEW DELHI 110029 |
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 |
ACTIVE DE RESUSCITATION GROUP |
active de resuscitation under guidance of VExUS by administering furosemide infusion started with 10mg/hr , maximum dose of 250mg/day. fluid restriction, limb elevation with application of compression bandage in patients with septic shock after randomisation. Duration of intervention will be 3 days. |
| Comparator Agent |
standard of care group |
no fluid restriction, no limb elevation with compression bandage, furosemide will not administered in patients with septic shock |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with septic shock resolution the lactate level less than 4 mmol/l and nor adrenaline dose less than 0.15microgram/kg/min.
2. Patients with cumulative positive fluid balance more than 2 litre and VExUS more than 1 |
|
| ExclusionCriteria |
| Details |
1.Patients age less than 18 years
2.Pregnancy and lactating women
3. CKD (chronic kidney disease)
4. CLD (chronic liver disease)
5.Solid organ and Hematopoietic stem cell transplant patients
6. Burn injury patients
7. Patient is on chronic dialysis
8. Anuric patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative negative fluid balance at day 3 and VExUS less than 1 |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| acute kidney injury on day 3 |
day 1 to 3 |
| Need of Renal Replacement therapy on day 3 |
day 1 to 3 |
| ventilator free days |
day 1 to 30 |
| vasopressor free days |
day 1 to 30 |
| 30 days mortality |
day 30 |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
12/09/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aims and objectives: This study aims to investigate the fluid de resuscitation have negative cumulative fluid balance on day 3 and patient centered outcomes
Methodology: All patient satisfying the inclusion criteria will be included in the study after obtaining written informed consent from patients’s relatives. Data collection includes demographic details, comorbidities, primary diagnosis, operative status, SOFA score, APACHE 2 score, baseline vitals ( Heart rate, blood pressure, respiratory rate, spo2) , baseline arterial blood gas ( P/F ratio, lactate ). The decision regarding de resuscitation will be taken by the intensive care physician as per study protocol. Before de resuscitation cumulative fluid balance will be measured at the time randomization. The patient will be randomized in 1;1 ratio in the following 2 groups, Active de resuscitation group ( fluid restriction, limb elevation with compression bandage application, administering furosemide infusion at rate of 10mg/hour , maximum dose upto 240 mg/day) and standard of care group. All patients included in the study will undergo daily measurement of fluid balance and VExUS score for first 3 days ( day 1,2,3). Target of intervention wil be equibalance of fluid on day 1, negative fluid balance on day 3 and VExUS less than 1. Patient will be excluded from studies if any of the following condition after randomization 1. Hypotension ( Mean arterial pressure less than 65 mmHg) 2. persistent and increasing vasopressor requirement ( Nor adrenaline more than 0.15 mcg/kg/min) 3. secondary infection 4. lactate > 4 mmol/l 5. Hypernatremia ( serum sodium > 155 meq/l) 6. Hypokalemia and metabolic alkalosis |