| 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
|
|
|
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
|
|
|
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. |