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CTRI Number  CTRI/2025/05/086174 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 12/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Early dialysis compared to standard care in sick children with infection and hypotension 
Scientific Title of Study   Early continuous renal replacement therapy versus standard care in critically ill children with septic shock: A pilot, single-centre, open-label, randomized controlled trial 
Trial Acronym  CRISIS Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prakriti Gupta 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Paediatric Intensive Care Unit, 2C3 ward, Department of Paediatrics, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9717413353  
Fax    
Email  prakritigupta93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Atul Jindal  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Paediatric Intensive Care Unit, 2C3 ward, Department of Paediatrics, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8224014667  
Fax    
Email  dratuljindal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prakriti Gupta 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Paediatric Intensive Care Unit, 2C3 ward, Department of Paediatrics, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9717413353  
Fax    
Email  prakritigupta93@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  Tatibandh, Raipur, Chhattisgarh 
Type of Sponsor  Government medical college 
 
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 Prakriti Gupta  AIIMS Raipur  2C3 Ward, PICU, AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH 
9717413353

prakritigupta93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early CRRT  Early continuous renal replacement therapy will be performed in addition to standard care in children with catecholamine-resistant septic shock 
Comparator Agent  Standard Care  Standard care includes fluid resuscitation, vasoactive support, organ organ support as per paediatric survivng sepsis guidelines. Antibiotic policy, source control, steroids, immunosuppressive therapy will be as per unit policy.  
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Catechomaline-resistant septic shock 
 
ExclusionCriteria 
Details  Anticipated PICU stay less than 24 hours, Need of renal replacement therapy at PICU admission as per conventional indications, did not give informed consent

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mortality  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
• Duration of inotropic support (hours)
• Ventilator-free days (VFDs)
• Trend of paediatric SOFA scores
• Duration of PICU stay, PICU free days
• Duration of hospital stay
• Survival at hospital discharge
• Need of RRT at 3 months follow-up
 
7 days, PICU discharge, hospital discharge, 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/05/2025 
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 Yet Recruiting 
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  

Introduction: Reported mortality rates in patients with refractory septic shock are as high as 85%, making this a critical area for intervention. While CRRT is weakly recommended in paediatric septic shock with AKI for fluid balance management, its overall impact on outcomes remains unclear. CRRT may offer multiple benefits including clearance of inflammatory mediators, correcting coagulopathy, and managing metabolic disturbances and fluid balance, which could improve patient outcomes.

Primary Objective: To compare 28-day mortality in children with catecholamine-resistant septic shock receiving early CRRT compared with those receiving standard care. 

 

Methodology: This will be a pilot, single-centre, prospective, randomized, open-label, controlled trial. It will be conducted at PICU, AIIMS Raipur, IndiaChildren aged 1 month-15 years with catecholamine-resistant septic shock (defined as VIS more than 15 for the purpose of the study), where endpoints of shock are not achieved or are in worsening trend despite 4 hours of adequate resuscitation, will be included in the study. These children should not have obstructive shock (cardiac tamponade, tension pneumothorax, massive pulmonary thrombo-embolism, elevated intra-abdominal pressure).  Children with anticipated PICU stay less than 24 hours, CPR before ICU admission, need of renal replacement therapy at PICU admission (as per conventional indications), known cases of autoimmune disease, cancer, chronic kidney disease, DCM, congenital heart disease, and those who did not give informed consent will be excluded from the study. Block randomization sequence will be computer generated. 60 patients will be randomly allocated in 1:1 ratio to 2 independent treatment groups using sealed envelope method: Group A (early CRRT + standard care) and Group B (standard care). Due to study design and intervention, blinding cannot be performed. For this study, CRRT will refer to CVVH and CVVHDF. Standard care will include fluid resuscitation, vasoactive and other organ support as per paediatric surviving sepsis guidelines with individualised targets. Antibiotic policy, source control, use of steroids and immunosuppressive therapy will be as per unit policy and same in both groups. 

 

Limitation and risks of the study: This will be pilot, single-centre, open label RCT with relatively small sample size. However, it will provide crucial preliminary safety and efficacy data to guide future large-scale trials. Patients in the intervention group will be exposed to CRRT related complications, and these adverse events will be rigorously monitored during the study. 

 

Benefits of the study: This study is an attempt to explore mortality benefit of early CRRT in a subgroup of critically ill children with catecholamine resistant septic shock with high mortality rates. 

 

 

 
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