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

07 Feb 2022

The date of last modification

Feb 08, 2022



Application Summary


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


Trial Details


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

  1. All male and female patients
  2. Aged 18 and above
  3. Diagnosed with dengue fever

Exclusion criteria

  1. Patients who have evidence of advanced plasma leakage or established on admission
  2. Known hypersensitivity to dextran
  3. Pregnant mothers & children
  4. Patients with acute kidney injury
  5. Advanced CKD (Stage V)
  6. Severe heart failure (NYHA class III & IV)
  7. Severe liver disease (Child’s C)
  8. Diabetics with autonomic dysfunction
  9. Patients on beta blockers, calcium channel blockers and sinus node blockers


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

15 beats per min from the supine position to erect position (within 3-5 min) at the time of examination.

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


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

Not relevant



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Rajarata University of Sri Lanka & University of Peradeniya





Secondary study sponsor (If any)







Trial Completion details


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