| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Tatibandh, Raipur, Chhattisgarh |
| 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 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
|
|
|
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, India. Children 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. |