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CTRI Number  CTRI/2023/11/060213 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 25/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intravenous fluid]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study on intravenous fluids in dengue shock 
Scientific Title of Study   Standard therapy versus PLasmalyte In children with Dengue Shock Syndrome (SPLID TRIAL): an open labelled randomised control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidushi Mahajan 
Designation  Associate Professor Pediatrics 
Affiliation  Government Medical College and Hospital Chandigarh 
Address  D block, Room No.411, Department of Pediatrics, Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Chandigarh
CHANDIGARH
-160030
India 
Phone  9646121531  
Fax    
Email  vidushimahajan2003@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Vidushi Mahajan 
Designation  Associate Professor Pediatrics 
Affiliation  Government Medical College and Hospital Chandigarh 
Address  D block, Room No.411, Department of Pediatrics, Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Chandigarh
CHANDIGARH
-160030
India 
Phone  9646121531  
Fax    
Email  vidushimahajan2003@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vidushi Mahajan 
Designation  Associate Professor Pediatrics 
Affiliation  Government Medical College and Hospital Chandigarh 
Address  D block, Room No.411, Department of Pediatrics, Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Government Medical College and Hospital, Sector 32, Chandigarh. 160030
Chandigarh
CHANDIGARH
-160030
India 
Phone  9646121531  
Fax    
Email  vidushimahajan2003@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi Infrastructure support: Government Medical College and Hospital , Chandigarh 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research, New Delhi 
Type of Sponsor  Government funding agency 
 
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 VIDUSHI MAHAJAN  Government Medical College and Hospital Chandigarh  A-22, Pediatric Emergency, Department of Pediatrics, GMCH,Sector 32, Chandigarh
Chandigarh
CHANDIGARH 		 9646121531

vidushimahajan2003@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A91||Dengue hemorrhagic fever,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NS or RL (1:1:1 Assignment)  The patients will be divided in the three groups: Plasma-Lyte group (PL), 0.9% sodium chloride (NS) group and Ringer Lactate (RL) based on the random allocation. The intervention in each group will include both bolus and maintenance fluid therapy.  
Intervention  Plasmalyte  Children in PL/NS/RL group will be started with 10-20ml/kg bolus of study fluid(4,6) in initial 30 mins, if the hematocrit falls, pulse rate and blood pressure stable and urine output between 0.5 to 1 ml/kg/hr, same fluid maintainence shall be started from 10 to 7ml/kg /hr for 2-4 hours, 5 to 3ml/kg/hr for 2-4 hrs and from 3 to 1.5 ml/kg/ hr for 2-4 hrs. If the hematocrit falls and there is no improvement in shock status or hematocrit rises, a second bolus of study fluid 10-20ml/kg over 15-30 minutes. Strict monitoring of hematocrit and urine output shall be done. If urine output is adequate and hematocrit normalizes,(4,6) this will be taken as end point of resuscitation which is usually achieved by 48 hours. Incase there is no improvement or clinical worsening and if the hematocrit shows rise, a third bolus may be considered. If the hematocrit falls with clinical worsening, we shall suspect bleed and blood transfusion shall be considered along with inotropes and maintenance fluids as per Holiday Segar formula. 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children suffering from dengue shock syndrome (DSS) will be enrolled.
DSS will be defined as DHF as well as hypotension, tachycardia, narrow pulse pressure (less than/equal to 20 mmHg) and signs of poor perfusion (e.g cold extremities, delayed capillary filling time, feeble pulses).
Dengue Haemorrhagic Fever (DHF) will be defined as a child fulfilling clinical criteria of dengue fever with bleeding tendencies viz., petechiae, ecchymoses or purpura, positive tourniquet test and/or skin, mucosal or gastrointestinal bleed with thrombocytopenia (<100000 cells per mm3) with increased vascular permeability (viz. > 20% increase in haematocrit, >20% decrease in haematocrit after fluid therapy, pleural effusion, ascites, hypoproteinemia). 
 
ExclusionCriteria 
Details  1) Children already received fluids from outside before enrolment in last 6 h
2) Children with cardiogenic shock
3) Known patient with chronic kidney disease as per KDIGO.
4) Severe malnutrition defined as per WHO.
5) Children whose parents deny consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
≥ 5mmol/L increase in serum chloride level within 48 hours (h) post-randomization.  Baseline, 48 hours  
 
Secondary Outcome  
Outcome  TimePoints 
hospital stay duration, need for colloid bolus, incidence of hyponatremia (serum sodium less than 135 mmol/L in the first 48 h of fluid management), new-onset AKI, standard base excess, serum lactate levels, renal replacement therapy, organ dysfunction (25)and serum magnesium levels.   first 48 hours, during hospital stay 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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   Phase 3 
Date of First Enrollment (India)   01/01/2024 
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)
Modification(s)  		 Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Deidentified data will be shared upon request.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  shared upon request.vidushimahajan2003@yahoo.co.in

  6. For how long will this data be available start date provided 01-12-2027 and end date provided 31-10-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Dengue Shock Syndrome (DSS) is the most serious manifestation of dengue fever. Standard therapy in DSS consists of fluid

therapy with isotonic crystalloids like Normal Saline (NS) or Ringer lactate (RL). Recently, the focus has shifted from unbalanced to

balanced fluids. Balanced crystalloids are sodium-based solutions with chloride content less than 154 mmol/L with added buffers

for better approximation of plasma composition. Balanced solutions like RL or Plasmalyte (PL) are isotonic and have chloride

concentration more like that of plasma, unlike NS. The optimal fluid therapy in DSS is mainly consensus based and currently there

is little evidence in children over which is the most optimal fluid for resuscitation in DSS. As the burden of dengue fever and

consequently DSS is on rise, it is of paramount importance to study the benefits and adverse effects of these fluids. Hence, we

planned this trial to examine if Plasmalyte (PL) causes less chloride rise and better preservation of renal functions compared to

standard therapy (i.e NS or RL) in children with DSS.

 
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