Home » Trials » SLCTR/2022/003
Dextran in Early Leakage Phase of Dengue Prevents Shock
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SLCTR Registration Number
SLCTR/2022/003
Date of Registration
The date of last modification
Nov 09, 2022
Trial Status
Scientific Title of Trial
Dextran in Early Leakage Phase of Dengue Prevents Shock
Public Title of Trial
A MULTI CENTER DOUBLE-BLIND RANDOMIZED PARALLEL-GROUP PHASE III CLINICAL TRIAL ON EFFECTIVENESS OF DEXTRAN 40 COMPARED TO NORMAL SALINE IN PREVENTING DENGUE SHOCK IN EARLY LEAKAGE PHASE OF PATIENTS WITH DENGUE HEMORRHAGIC FEVER
Disease or Health Condition(s) Studied
Dengue haemorrhagic fever
Scientific Acronym
DELPODS Study
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1272-4389
Any other number(s) assigned to the trial and issuing authority
ERC/2021/79:FAHS, UoR
What is the research question being addressed?
Does dextran 40 infusion in early leakage phase of patients with dengue haemorrhagic fever compared to infusion of normal saline prevent dengue shock syndrome?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting Professorial medical units of Teaching Hospitals Anuradhapura and Peradeniya.
Randomization method Permuted block randomization will be done by a person who is not part of the study. Varying block sizes will be used, and block sizes are blinded to investigators to avoid predictability.
Intervention and control Infusion of 5ml/Kg (maximum 250ml) of dextran 40 over two hours during early critical phase of dengue haemorrhagic fever.
This will be compared with 5ml/Kg (maximum 250ml) of normal saline infusion over two hours (standard/current practice).
Participants will be randomized to receive dextran or normal saline when the urine output drops less than 0.5ml/Kg/hour for two hours.
Reduction of urine output less than the minimum obligatory amount in a patient with dengue haemorrhagic fever is an important clinical feature. It indicates intravascular fluid depletion and possible pre-renal acute kidney injury.
Commercially available dextran 40 is dissolved in normal saline, therefore both groups will receive equal volumes of normal saline as a part of the study. The only difference between two groups is one group receiving five grams of Dextran 40 in addition to normal saline per dose.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Reduction of proportion of compensated or uncompensated shock by 15% in the dextran group compared to control group Compensated shock: Tachycardia with narrow pulse pressure (< 30mmHg), Decompensated shock: Systolic blood pressure less than 90mmHg and /or mean arterial pressure less than 65mmHg |
[ Calculated after leakage phase (48 hour period) ] |
|
2.
Proportion of patients with reduction of in pulse rate by 20% one hour after drug administration |
[ One hour after drug administration ] |
|
3.
Proportion of patients with blood pressure improvement by 20% one hour after drug administration |
[ One hour after drug administration ] |
|
4.
Proportion of patients with pulse pressure improvement by 20 % one hour after drug administration |
[ One hour after drug administration ] |
|
5.
Proportion of patients with resolution of postural tachycardia at the end of the study drug administration. - The pulse rate to come to baseline or to the lowest level - whichever is lower Postural tachycardia is rise of the pulse rate
Baseline for postural tachycardia is resting pulse rate at lying position when the patient is euvolemic and afebrile |
[ One hour after drug administration ] |
|
6.
Proportion of patients with improved urine output i.e more than 0.5ml/Kg/hour |
[ The first measurement is one hour after study drug administration and hourly thereafter for 48 hrs or end of leaking phase. ] |
Secondary outcome(s)
|
1.
Duration of maintenance of normal urine output (> 0.5ml/kg) after study drug administration |
[ One hourly after study drug administration for 48 hours ] |
|
2.
Percentage change of inferior vena cava (IVC) diameter post drug administration |
[ One hour after drug administration ] |
|
3.
Amount of total fluid needed to maintain haemodynamic stability over the critical phase |
[ Calculated at the end of the leaking phase ] |
|
4.
Number of rescue fluid boluses needed over 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. |
[ 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. ] |
Target number/sample size
218 (109 in one arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-02-09
Anticipated end date
2026-12-31
Date of first enrollment
2022-10-07
Date of study completion
Recruitment status
Recruiting
Funding source
Self funded
Regulatory approvals
Not relevant
Status
Approved
Date of Approval
2021-12-09
Approval number
ERC/2021/79
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. |
| Institutional Address: | Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. |
| Telephone: | +94 (0) 25 2053633 |
| Email: | erc@med.rjt.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Chamara Sarathchandra
Senior lecturer in Medicine
Dr. Chamara Sarathchandra
Department of Medicine
Faculty of Medicine & Allied Sciences
Rajarata University of Sri Lanka.
0252227706
0774743366
0252227706
nilupulchamara@gmail.com
Contact Person for Public Queries
Dr. Ruwanthi Bandara
Senior lecturer in Medicine
Dr. Ruwanthi Bandara
Department of Medicine
Faculty of Medicine
University of Peradeniya
0812396470
077801677
0812389106
ruwanthibandara@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial will be shred after de-identification and immediately following publication, no end date among those whos purposes have been approved by an independent review committee identified for this purpose. The data may be used to achieve the objectives discussed and for meta analysis. For any further use and to obtain the data, please inquire at nilupulchamara@gmail.com. Data will be available for use immediately after publication indefinitely.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
