FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/016169 [Registered on: 26/10/2018] Trial Registered Prospectively
Last Modified On: 21/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of targeted treatment based on measuring oxygenation by central venous access versus usual care in children with septic shock 
Scientific Title of Study   Superior venacaval oxygen saturation monitoring (Intermittent / Continuous) based Goal Directed Therapy vs Standard Care in Children with Septic Shock: An Open Label Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namita Ravikumar 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Reasearch 
Address  Pediatric Emergency and Intensive Care Unit Department of Pediatrics PGIMER Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8826582654  
Fax    
Email  namitu.ravi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar Baranwal 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Reasearch 
Address  Pediatric Emergency and Intensive Care Unit Department of Pediatrics PGIMER Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8826582654  
Fax    
Email  baranwal1970@gmail.com  
 
Details of Contact Person
Public Query  
Name  Namita Ravikumar 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Reasearch 
Address  Pediatric Emergency and Intensive Care Unit Department of Pediatrics PGIMER Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8826582654  
Fax    
Email  namitu.ravi@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research Sector 12 Chandigarh 
 
Primary Sponsor  
Name  PGIMER 
Address  PGIMER Sector 12 Chandigarh 160012 
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 Namita R Kumar  Postgraduate Institute of Medical Education and Research  Pediatric Emergency and Intensive Care Unit Department of Pediatrics PGIMER Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 8826582654

namitu.ravi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee PGIMER Chandigarh  Approved 
Institutional Ethics Committee PGIMER Chandigarh  Approved 
Institutional Ethics Committee PGIMER Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goal directed therapy group  GDT group will undergo IJV central line insertion and targeting ScvO2 more than 70% by fluids, vasoactive and blood products. ScvO2 may be continuous or intermittent. 
Comparator Agent  Standard care group  Standard care group will receive treatment for septic shock based on existing unit protocol which is fluid and vasoactive therapy based on clinical hemodynamic parameters 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  i. All children ≥ 6 month to <12 years
AND
ii. Presenting to Pediatric ER with clinical septic shock
OR
iii. Developing it within 24 hours of admission to Pediatric ER

Septic shock will be defined by presence of clinically suspected sepsis with cardiovascular organ dysfunction i.e., children with persistent hypotension (MAP <5th centile for age and gender) despite 40 ml/kg of resuscitation fluid and requiring vasoactive drug infusion during first 1 hour. 
 
ExclusionCriteria 
Details  i. Contraindications for central neck venous line insertion (IJV or Subclavian vein) like bleeding tendencies, or not accessible for line insertion due to short neck or local disease.
ii. Children already on inotrope with inotrope score of >10 at arrival to our hospital.
iii. Children with known or suspected congenital heart disease
iv. Immunocompromised patients, e.g., primary immunodeficiency disorders, HIV (exposed or positive), patients with malignancies or other diseases on immunosuppressive medications including steroids.
v. Children with chronic illness like tuberculosis, chronic liver disease, chronic kidney disease, chronic respiratory disease etc.
vi. Known Inborn errors of metabolism
vii. Children with shock primarily due to diarrhea and severe dehydration.
viii.Children with suspected healthcare associated infection 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mortality  14 day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the baseline and trend of ScvO2 in the two groups  5 days 
To compare the time to attainment of end points of shock resuscitation (as defined by BP less than 5th centile MAP for the age and gender, CFT 2 sec, SpO2 70%, and lactate 2 mmol/L)  5 days 
To study the correlation of ScvO2 with lactate in the two groups.  5 days 
To compare Organ dysfunction scores (pediatric SOFA and PeLOD) over first 7 days in the two groups  7 days 
Duration of vasoactive support in the two groups  5 days 
Inotrope free days in 120 hours in the two groups  5 days 
Length of Acute Care Area stay  28 days 
Acute Care Areas free days in 14 days in the two groups  14 days 
Length of hospital stay  28 days 
To compare the effect of continuous versus intermittent ScvO2 monitoring on achievement of end points as defined above and mortality.  14 days 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/10/2018 
Date of Study Completion (India) 30/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2019 
Estimated Duration of Trial   Years="2"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 This study will be conducted in Pediatric emergency and PICU, PGIMER, Chandigarh. Children between 6 months to 12 years of age presenting with septic shock will be randomized into 2 groups: Goal directed therapy group and Standard care group.Goal directed therapy group will be further divided into continuous ScvO2 and intermittent ScvO2 group. GDT group will receive treatment targeting ScvO2>70% including fluids, vasoactive and blood products and Standard care will follow existing unit protocols. Outcome parameters like mortality, duration of stay and vasoactive support will be compared. 
Close