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CTRI Number  CTRI/2025/06/088778 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comparison of routinely used fluids]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Choice of resuscitation fluids in Dengue shock in children. 
Scientific Title of Study   Comparison of Acetate-based, Lactate-based and Multiple Electrolyte Solution versus saline (MeSLAc trial) in Dengue shock – A multicenter randomized controlled trial  
Trial Acronym  MeSLAcD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jhuma Sankar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Division of Pediatric Pulmonology and Intensive Care Department of Pediatrics Room 839, Mother Child Block, AIIMS

South
DELHI
110016
India 
Phone  9818399864  
Fax    
Email  jhumasankar@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Jhuma Sankar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Division of Pediatric Pulmonology and Intensive Care Department of Pediatrics Room 839, Mother Child Block, AIIMS

South
DELHI
110016
India 
Phone  9818399864  
Fax    
Email  jhumasankar@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Jhuma Sankar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Division of Pediatric Pulmonology and Intensive Care Department of Pediatrics Room 839, Mother Child Block, AIIMS

South
DELHI
110016
India 
Phone  9818399864  
Fax    
Email  jhumasankar@aiims.edu  
 
Source of Monetary or Material Support  
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi  
Address  AIIM Ansari Nagar New Delhi 110029 
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 Jhuma Sankar  All India Institute of Medical Sciences, New Delhi  Pediatric Emergency and ICU, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
South
DELHI 
911129576864

jhumasankar@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A90||Dengue fever [classical dengue],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balanced crystalloids  Plasmalyte or Ringer’s lactate or Ringers acetate as resuscitation fluid  
Comparator Agent  Saline  Saline will be used as resuscitation fluid 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children 2 month to less than 17 years with features of Dengue shock defined as children with probable dengue fever ; a positive test by rapid diagnostic test; and have at least two clinical signs of decreased perfusion with or without hypotension  
 
ExclusionCriteria 
Details  Children with culture positive sepsis or suspected septic shock
Children receiving fluid boluses before enrollment
Children with cardiogenic shock.
Children whose parents refuse to give an informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of children with Major Adverse Kidney events - new onset or progressive AKI, in-hospital mortality, new renal replacement therapy, or persistent renal dysfunction at 30 days   Within 30 days of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of children with hyperchloremia  In the first 7 days 
Proportion of children attaining shock resolution  In first 24 hours 
Mortality  Till day 30 
 
Target Sample Size   Total Sample Size="560"
Sample Size from India="560" 
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)   18/12/2025 
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="3"
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  

Septic shock and dengue shock syndrome are important cause of mortality and morbidity in children. Fluid resuscitation is a key intervention in the management of septic shock and dengue shock syndrome. The purpose of fluid resuscitation is to replenish the intravascular volume in order to improve microcirculation and tissue perfusion, and maintain normal cardiac index.

The WHO guideline issued in 2009 recommends prompt administration of crystalloids (saline or Ringers lactate) in patients with dengue shock followed by sequential tapering of the crystalloid regimen. Saline has been routinely used as bolus therapy in severe dengue in the first hour as it is inexpensive and readily available with an efficacy similar to colloids with respect to shock resolution and mortality.  

            Normal saline has its own set of undesired physicochemical actions. It is slightly hypertonic to plasma and is both hypernatremic as well as hyperchloremic relative to plasma. Emerging data strongly indicate the increased incidence of hyperchloremic metabolic acidosis and consequently, acute kidney injury associated with infusion of boluses of normal saline in critically ill adults and children in shock. Balanced crystalloids (BC) have a composition resembling plasma with a lower chloride concentration than saline.  Some balanced crystalloids (e.g., multiple electrolytes solution (MES) also known as Plasma-Lyte A, lactated Ringer’s, Ringer’s acetate) have been reported to be associated with decreased risk of metabolic disturbances such as hyperchloremia and metabolic acidosis as compared to saline in children from diverse patient settings.

In children, in a recently concluded large multicentre trial by our group comparing balanced crystalloids and saline, there was significant reduction in the incidence of AKI (21% vs. 39%) and other metabolic derangements like hyperchloremia and metabolic acidosis with the use of balanced crystalloids. Even though the fluids were mainly used as bolus therapy and not maintenance, the protective effect on kidneys and metabolic parameters was observed with the use of BC.

Among the balanced crystalloids, Ringers Lactate is widely used in dengue for ongoing fluid therapy although there is no robust evidence to support its use. There are different BCs available in the market now apart from Ringers lactate such as Ringers acetate and Multiple electrolyte solution. There are few studies comparing various types of colloids with saline and Ringers lactate but none comparing the various crystalloids alone. Our rationale for conducting the present study is guided by lack of pediatric data comparing various crystalloids in dengue shock.  It needs to be seen which of these crystalloids have a better metabolic profile and are reno protective as compared to saline in dengue.

 
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