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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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