The aim of this study is to evaluate the effect of use of albumin add-on therapy to loop diuretic for the management of pleural effusion in mechanically ventilated ill children
Design
Two arm, double blind, parallel group clinical trial, phase 2. In this study, 50 patients between 1 to 12 years old, admitted to PICU , who have pleural effusion, will randomly be assigned in two groups of only lasix or lasix plus albumin.
Settings and conduct
This is a double blinded study on 50 patients admitted in PICU of Emam Hosein hospital of Esfahan , who have pleural effusion, and receive only lasix or lasix plus albumin and will be compared about decrease in volume of pleural effusion
Participants/Inclusion and exclusion criteria
Inclusion criteria: ICU-admitted children;
Under mechanical ventilation;
Diagnosis of pleural effusion;
Age range of 1-12 years old;
Systolic blood pressure above 100 mmHg;
Serum albumin levels of less than 2.5 mg/dl.
Intervention groups
Intervention group: 1 gr/kg albumin 20% plus 2 mg/kg furosemide for three days. Control group: treatment with 2 mg/kg furosemide plus 5 ml/kg of saline 0.9% as placebo for 3 days.
Main outcome variables
Volume of pleural effusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039739N4
Registration date:2020-02-17, 1398/11/28
Registration timing:registered_while_recruiting
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Mohammadreza Habibzadeh siahroodkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3532 0551
Email address
M.habibzadeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the use of albumin add-on therapy to loop diuretic for the management of pleural effusion in mechanically ventilated ill children
Public title
Treatment of pleural effusion by albumin and lasix
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ICU-admitted children
Under mechanical ventilation
Diagnosis of pleural effusion
Age range of 1-12 years old
Systolic blood pressure above 100 mmHg
Serum albumin levels of less than 2.5 mg/dl
Exclusion criteria:
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (random number table): even numbers will be allocated to control group (treatment by lasix) and odds numbers will be allocated to intervention group (treatment by Lasix and albumin)
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and evaluator of the outcomes are not aware of the kind of drugs and drugs will be provided by the researcher and will be given to the nurses for usage.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezarjerib street
City
Esfahan
Province
Isfehan
Postal code
ندارد
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.MUI.MED.REC.1398.512
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
Primary outcomes
1
Description
volume of pleural effusion
Timepoint
Every day up to 3 days
Method of measurement
FAST sonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: treatment with furosemide (2 mg/kg; Aburaihan Company; Iran) plus 5 ml/kg of saline 0.9% as placebo for 3 days
Category
Treatment - Drugs
2
Description
Intervention group: 1 gr/kg albumin 20% (5 ml/kg; Alborzdarou; Iran) plus furosemide (2 mg/kg; Aburaihan Company; Iran) for three days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Mohammadreza Habibzadeh
Street address
Emam Khomeini
City
Esfahan
Province
Isfehan
Postal code
ندارد
Email
gsmhabibzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezarjerib
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 31 3668 0042
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available