Download If you decide to participate in the study, an INFORMED CONSENT is

PHILIPPINE CHILDREN’S MEDICAL CENTER
Quezon Avenue corner Agham Road, Quezon City
PARENT/GUARDIAN INFORMATION SHEET
INFORMED CONSENT FOR MEDICAL RESEARCH
Study Title: The Efficacy of Totilac™ Infusion Compared to Lactated Ringers
Solution in the Reversal of Compensated Pediatric Dengue Shock Syndrome III at
Philippine Children’s Medical Center
Simplified Title: A Study to Investigate the Efficacy of Totilac Fluid IV in the treatment of
dengue shock syndrome III at Philippine Children’s Medical Center
Principle Investigator: Katrine Anne R. de Lara M.D.
Supervising Investigator: Florentina Uy-Ty M.D.
Telephone Number +639255000504, PCMC IRB (02) 9246601
Your child is invited to participate in a research study conducted by Katrine Anne R. de
Lara M.D. and Florentina Uy-Ty M.D, from the Philippine Children’s Medical Center
Your child’s participation is voluntary. Before you decide on whether you want your child
to take part in the study, please be free to read the information provided below and
discuss it with friends and family if you wish. The doctors involved will be free to discuss
concepts about the study to you and your child. If you and/or your child decide to
participate, you will be asked to sign this form. You will be given a copy of this form.
What is the purpose of this study?
The purpose of this research is to investigate an IV fluid, Totilac for the treatment of
Dengue Shock Syndrome III. This drug is already available in the market as a new IV
fluid for dengue shock syndrome. This fluid is to be given via an intravenous line.
To explain its action, look at the following diagram:
This is a cross section of your veins. The blue section is the extravascular space
wherein our blood goes through. In dengue shock, look below on what will
happen
The blue portion (where blood
goes through, develops pores or
holes leading to a leak in plasma
of blood causing decrease or
sluggishness in blood flow
Decreased plasma, increase in
hematocrit, which signifies
thickness of blood. The thicker
the blood, the slower the blood
flow, decreasing oxygen supply
to tissues
Totilac will act to bring back the plasma which goes through the pores back to
the intravascular space decreasing the amount of leak through the pores. Its
proposed advantage is that it would only take smaller amount of fluid compared
to your normal IV fluid. This study will investigate the efficacy of Totilac as the
initial IV fluid over 24 hours for dengue patients who would go into dengue shock.
The information collected will be analyzed to find out whether the treatment is working.
The information may be used for scientific presentations.
Demographic
Hour
Hour
Hour Hour Hour Hour Hour Hour Hour Hour
0
1
2
3
4
5
6
9
12
24
X
Data
Medical History
X
Medication
X
History
Body weight and x
x
height
Glasgow
coma x
x
x
x
x
x
x
x
x
X
x
x
x
x
x
x
x
x
X
x
x
x
x
x
x
x
x
X
scale, Vital signs
Fluid
balance x
(Input,
output,
urine output,)
Clinical signs of x
overload
(periorbital,
abdominal
circumference,
bipedal
edema
etc)
Chest Xray
X
CBC
x
X
x
X
X
X
x
x
X
Dengue blot or X
Dengue NS1 Ag
Serum
x
X
blood X
X
electrolytes
Venous
x
gas
End
organ x
x
laboratories
Why is your child being invited to participate in the study?
Your child has a disease called dengue fever. Dengue fever has 3 phases: febrile phase
of the phase wherein the child has fever that will usually last for 2-7 days. After which,
the patient will go into the critical phase. Why critical? It is because during this phase,
your child’s blood vessels would have tiny holes in which the plasma or the water of the
blood may go out through. This is what we call increase in plasma permeability.
What happens next is that the remaining blood inside would become viscous or thick
which would be reflective on the hematocrit, or the thickness of the blood. Our blood,
which is important in the circulation of oxygen to our body organs, due to its increase in
thickness will cause blood to circulate slower, hence oxygen delivery will be decreased.
This is what we call shock or the ineffective circulation of oxygen to our vital organs.
This is a complication of dengue hemorrhagic fever. Your child may or may not go
through this complication. If your child does go through shock, this study will then be
conducted to them if you decide to give us your consent. At least 100 children between
ages 2-18 will take part in the study.
Does your child have to take part in the study?
You and your child’s participation is voluntary. It is up to you to decide on whether you
want to take a part in it or not. You are free to discuss this with your family members or
with other doctors if necessary. This will not affect your child’s medical treatment or your
relationship with your doctors.
If you will decide to withdraw your consent to the study, your child’s future care will not
be affected.
If you decide to participate in the study, an INFORMED CONSENT is provided at the
back which you will have to sign. You will be given a copy of the informed consent.
What will happen to your child if he/she will be a part of the study?
This study is to be done for the first 24 hours of dengue shock . Your child will be either
given Totilac or the standard treatment of dengue shock which is an IV fluid called
Lactated Ringers solution. How will we know whether of the two will be given? The
doctor at your ward, during the shock episode will open an envelope which will
contain the words Totilac or lactated ringers. She will pick from the envelope and
whatever she picks out , that will be the fluid that will be given. Totilac or plain
lactated ringers solution is given to increase the amount of blood circulating in the blood
vessels to decrease the blood’s viscosity or thickness to improve the oxygen that will be
circulating to his/her vital organs.
What procedures will be done to your child?
Personal details: Age, Sex, Height, Weight
Vital signs: Blood pressure, heart rate, respiratory rate, temperature, quality and
temperature of distal pulses will be taken every hour until the 6th hour, then at the 9th,
12th and 24th hour.
Physical Examination: Your doctor will make a physical examination of your child’s
health.
Procedure: 2 intravenous sites will be inserted, one is for the IV fluid and one for
collection of blood samples. This is an IV site which is inserted for the sole purpose to
collect blood so that multiple needle punctures will not be done to your child
Blood Samples: End organ function laboratories or blood samples that will measure the
function of your child’s vital organs will be taken from an extraction site is taken during
the time of shock and after 24 hours. This is a measure from which your doctors will be
able to see whether the shock has affected any of your child’s vital organs and hence
correct the malfunction if there is any. A total of 10 cc will be taken for all
laboratories during the duration of the study. All will be taken via the extraction IV
line. See table below.
IV infusion: Totilac, which will be provided by the investigators or Lactated Ringers
solution will be given through the intravenous site for 1 hour. After which, your child’s
vital signs will be monitored during the next succeeding hours until after 24 hours after
shock. If the shock does not improve after the 1st hour, the sample fluid will be given for
another hour. If the shock is not reversed after the second bolus of IVF a colloid solution
will be given as per world health organization protocols.
Other contraptions: An indwelling catheter is to be inserted to accurately measure your
child’s urine output which is a part of shock protocol.
What does your child have to do?
Your child will have to lie down, he/she will not be allowed to sit up or stand up or walk
during the course of the dengue shock which is a part of standard shock protocol. At
first, your child will not be allowed to have any food or drink by mouth for the first 6
hours of shock.
What are the possible risks of taking part in this study?
Your child will have an intravenous site inserted for blood collection and fluid
resuscitation. He/ she will have an indwelling catheter inserted which may cause mild
discomfort. Every effort will be made to reduce the anxiety by the patients.
How much blood will be taken?
Approximately 10 ml or 2 teaspoons will be taken during the whole duration of the study.
What are the possible benefits?
The information that we will get will be able to help us develop, a better treatment for
your child and other children with dengue shock syndrome.
What will happen if I don’t want my child to carry on with the study?
You can choose not to allow your child to take a part on this study. This choice will not
have an impact on your child’s present or future health. There will be no penalty or loss
of benefits.
Will this be confidential?
If you agree to take a part in this study, some of your child’s medical records will be
collected and may be looked at by representatives of the ethics or research committees
and by other hospital authorities to check that the study is being done correctly. Data
from the study may be published in scientific journals. The personal data of your child
will be kept confidential. He/she will not be personally identified.
What will happen to the results of this study?
All data that will be collected will be kept on file, analyzed and results may be
considered for publication or presentation at symposiums and post graduate
conferences. The child’s identity will be well protected.
Will my child or I get paid for my child’s participation?
No. Your child will not receive any payment for taking part but the study drug will be
made available to your child for free and you will not be required to pay for any study
procedures in excess of the standard protocol.
Has anyone approved this study?
This study has gone through the Institutional Review Board, Ethics Committee of
Philippine Children’s Medical Center hence international guidelines of good clinical
practice are being followed. Also, Totilac is also approved by ouf Bureau of Food
and Drugs for dengue fever here in the Philippines
Contact Information for Further Information
If you have any questions regarding your child’s right as a research participant or if you
have any other questions, you can call Dr. Mary Ann F. Aison, Chairman of the IRB-EC
at Philippine Children’s Medical Center (9246601 local 356) or Dr Katrine Anne R. de
Lara 09255000504 or PCMC IRB (02)9246601
Parent/Guardian
Informed Consent Form
Study Title: The Efficacy of Totilac™ Infusion Compared to Lactated Ringers
Solution in the Reversal of Compensated Pediatric Dengue Shock Syndrome III at
Philippine Children’s Medical Center
Simplified Title: A Study to Investigate the Efficacy of Totilac Fluid IV in the treatment of
dengue shock syndrome III at Philippine Children’s Medical Center

I have read and understood the information provided about the study

I affirm that the study has been explained to me and my child, all questions were
answered sufficiently and I was given ample time to decide.

I understand that the participation of my child is voluntary and that we are free to
withdraw our consent whenever we decide to without my child’s rights to medical
care being affected

I understand that I can decide not to allow my child to participate even if they
have given assent.

I understand that my child ‘s identity will be kept confidential.

I agree that my child’s blood, xray or urine that will be collected can be used for
this study

I agree to consent my child to participate in this study
A copy of the information sheet and signed informed consent will be given to you to
keep.
_________________________________
Patient’s Name (Please print)
__________________________________
Parent/Guardian Name (Printed Name and Signature)
I have been fully informed the parent/guardian about the full aspects of the trial and was
able to answer all questions asked to me.
_____________________________________
Full name of Investigator ( Printed Name and Signature)
Witness
_____________________________________
Printed Name and Signature