| CTRI Number |
CTRI/2024/04/066542 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intravenous fluids ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of Plasmalyte-A versus 0.9% normal saline as intravenous fluid therapy on serum bicarbonate levels in children with Dengue. |
|
Scientific Title of Study
|
Plasmalyte-A versus Normal saline for fluid replacement therapy in Dengue in children: A Randomized Controlled 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 |
KAMRAN AFZAL |
| Designation |
PROFESSOR |
| Affiliation |
Department of Pediatrics, Jawaharlal Nehru Medical College , AMU, Aligarh |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College,
Aligarh Muslim University,
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
05712721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMRAN AFZAL |
| Designation |
PROFESSOR |
| Affiliation |
Department of Pediatrics, Jawaharlal Nehru Medical College , AMU, Aligarh |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College,
Aligarh Muslim University,
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
05712721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HAZIQ AHMAD CHAND |
| Designation |
RESIDENT IN PEDIATRICS |
| Affiliation |
Department of Pediatrics, Jawaharlal Nehru Medical College, AMU, Aligarh |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, Aligarh Muslim University,
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9760937408 |
| Fax |
|
| Email |
haziq.chand55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,AMU,Aligarh,Uttar Pradesh 202002 India |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, AMU, Aligarh, Uttar Pradesh |
| 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 |
| KAMRAN AFZAL |
PEDIATRICS EMERGENCY, WARD AND PICU |
(1) Pediatrics Emergency, Second Floor, Emergency and Trauma Centre,Jawaharlal Nehru Medical College;
(2) Pediatric Wards No. 16/17/18 and Paediatric Intensive Care Unit, Jawaharlal Nehru Medical College
Aligarh
UTTAR PRADESH |
0571-2721182
drkafzal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], (2) ICD-10 Condition: A91||Dengue hemorrhagic fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Baseline clinical data and laboratory data will be recorded. Intravenous fluid therapy will be given as per the disease classification.
(1) Dengue with warning signs: 0.9 % NS will be given as IV infusion at 5–7 mL/kg/h for 1–2 hours. reassess the patient’s condition When stable, IV fluid will be reduced to 3–5 mL/kg/h for 2–4 and then reduced to 2–3 mL/kg/h till patient is able to take orally adequately.
(2) Dengue with compensated shock: Start IV fluid resuscitation with 0.9 % NS at 10 ml/kg/hour over one hour. Then reassess the patient’s condition. a) If the patient’s condition improves, intravenous fluids should be gradually reduced to 5–7 ml/kg/hr for 1–2 hours, then to 3–5 ml/kg/hr for 2–4 hours, then to 2–3 ml/kg/hr (b) If vital signs are still unstable (i.e. shock persists), check the haematocrit after the first bolus. If the haematocrit increases or is still high, repeat a second bolus of
crystalloid solution at 10–20 ml/kg/hr for one hour. After this second bolus, if there is
improvement, reduce the rate to 7–10 ml/ kg/hr for 1–2 hours, and then continue to
reduce as above if haematocrit decreases compared to the initial reference haematocrit. Patients will be given 0.9 % NS for first 6 hours of intervention. After 6 hours, type of fluid and rate of administration will be decided by the treating physician. IV fluid will stopped after 24 hours of patient becoming stable.
(3) Dengue with decompensated shock: initiate with IV 0.9 % NS @ 20 ml/kg over 15-30 min. If patient improves, treat as for compensated shock. Patients will be given 0.9 % NS for first 6 hours of intervention. After 6 hours, type of fluid and rate of administration will be decided by the treating physician. IV fluid will stopped after 24 hours of patient becoming stable.
|
| Intervention |
Plasmalyte-A |
Baseline clinical data and laboratory data will be recorded. Intravenous fluid therapy will be given as per the disease classification.
(1) Dengue with warning signs: Plasmalyte-A will be given as IV infusion at 5–7 mL/kg/h for 1–2 hours. reassess the patient’s condition (vital signs, capillary refill time, haematocrit, urine output) . When stable, IV fluid will be reduced to 3–5 mL/kg/h for 2–4 and then reduced to 2–3 mL/kg/h till patient is able to take orally adequately.
(2) Dengue with compensated shock: Start IV fluid resuscitation with Plasmalyte-A at 10 ml/kg/hour over one hour. Then reassess the patient’s condition (vital signs, capillary refill time,
haematocrit, urine output).(a) If the patient’s condition improves, intravenous fluids should be gradually reduced to 5–7 ml/kg/hr for 1–2 hours, then to 3–5 ml/kg/hr for 2–4 hours, then to 2–3
ml/kg/hr, and then further depending on haemodynamic status, which can be maintained for up to 24–48 hours. (b)If vital signs are still unstable (i.e. shock persists), check the haematocrit after the first bolus. If the haematocrit increases or is still high, repeat a second bolus of
crystalloid solution at 10–20 ml/kg/hr for one hour. After this second bolus, if there is
improvement, reduce the rate to 7–10 ml/ kg/hr for 1–2 hours, and then continue to
reduce as above if haematocrit decreases compared to the initial reference haematocrit. Patients will be given Plasmalyte A for first 6 hours of intervention. After 6 hours, type of fluid and rate of administration will be decided by the treating physician. IV fluid will stopped after 24 hours of patient becoming stable.
(3) Dengue with decompensated shock: initiate with IV Plasmalyte-A @ 20 ml/kg over 15-30 min. If patient improves, treat as for compensated shock. Patients will be given Plasmalyte A for first 6 hours of intervention. After 6 hours, type of fluid and rate of administration will be decided by the treating physician. IV fluid will stopped after 24 hours of patient becoming stable.
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of dengue based on clinical features and laboratory reports (including Dengue IgM,IgG and NS1 levels) requiring intravenous fluid therapy |
|
| ExclusionCriteria |
| Details |
(1)Comorbid conditions that may affect the outcome of the study like chronic liver disease, congenital heart disease, etc
(2) Allergies to Normal saline (0.9%) or Plasmalyte-A
(3)Patients with PeLOD-2 score of more than or equal to 14
(4) Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in plasma bicarbonate level |
At enrollment and after 6 hours of administration of replacement fluid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total volume of fluid received, Fluid rate, urine output and proportion with fluid overload |
6 hours |
| Serum electrolytes (Na, K, Ca), urea, creatinine, glucose and haematocrit level |
0 hours and 6 hours |
| Glasgow coma scale |
6 hours |
| Duration of hospital stay and in-hospital mortality |
till discharge or in-hospital mortality |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/05/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This randomized controlled trial is designed to compare, in hospital setting, two isotonic fluids, i.e. Plasmalyte-A and normal saline for fluid replacement in children with Dengue requiring IV fluid therapy. Fluid shall be administered as per the WHO treatment guidelines for fluid replacement in children with dengue. The primary outcome measure of the study is change in plasma bicarbonate level at 6 hours from baseline. Secondary outcome measures include total volume of fluid received, fluid rate, urine output, proportion of patients with fluid overload, serum levels of sodium, potassium, urea, creatinine, glucose, hematocrit level, modified Glasgow Coma Score and in-hospital mortality. |