Determination of the effect of inhaled heparin on the reduction of the duration of antibiotic therapy based on clinical pulmonary infection severity score(CPIS) and the serum level of pro-calcitonin in patients of our study.
Design
This study was single blind clinical trial with parallel groups that using randomized block method and available sampling was performed among patients admitted in the ICU in two groups of intervention and control and the sample size in each group was 21patients.
Settings and conduct
After identifying the intervention and control groups and after the randomization process in the hospital's intensive care unit, 2 ml of the heparin injected into the 2-cc syringe is drawn into the nebulizer in the patient's intervention group . In the same way and in the same syringe, placebo which is distilled water, is drawn into the nebulizer in the control group.Standard treatment is continued in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Patients on the basis of CPIS>=6 suspected with ventilator associated pneumoniae and age above 18 years of age.
Exclusion criteria:
Patients who on mechanical ventilation< 48 h, cancer patients , chronic immune deficiency / chronic infections / concurrent infections at other sites /Do not resuscitate patients
renal replacement therapy , heparin or Low molecular weight heparin or other anticoagulants, having an Body mass index> 40, having a history of heparin allergy or a history of Hparin induced thrombocytopenia, history of bleeding in the past 3 months, or hemorrhagic disorders, intra cranial hemorrhage over the last year
Intervention groups
The intervention group in our study includes patients who receive nebulized heparin
The control group in our study includes patients who receive a placebo that is distilled water
Main outcome variables
Duration of antibiotic treatment; procalcitonin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140310016917N8
Registration date:2019-07-11, 1398/04/20
Registration timing:registered_while_recruiting
Last update:2019-07-11, 1398/04/20
Update count:0
Registration date
2019-07-11, 1398/04/20
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of inhaled heparin on duration of antibiotic therapy in patients with ventilator associated pneumonia
Public title
Inhaled heparin in pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are included in the study according to the score of the severity of pulmonary infection index (>=6) and age above 18 years old.
Exclusion criteria:
Mechanical ventilation less than 48 h during hospitalization
Cancer and immunedeficient patients
chronic infection and coinfection in other sites of body
Do not resuscisate patients
CRRT dependency
Theraputic dose of any anticoagulants
BMI>40
History of allergy to heparin and HIT
History of bleeding in 3 month ago and bleeding tendency
ICH in 1year ago
possibility of epidural catheter insertion during next 48 h
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
A blood sample to examine the relevant parameters and a sample of tracheal secretions for culture and antibiogram
Randomization (investigator's opinion)
Randomized
Randomization description
Out of 42 subjects who entered the study by random block method, Individuals are randomly assigned to both interventional and non-interventional groups (with placebo)by statistical random generator software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Once the subjects in the study groups have been identified, the drug and placebo are placed in the same syringes as they are in appearance, and thus patients will not be informed of the contents inside it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.GUMS.REC.1398.117
Health conditions studied
1
Description of health condition studied
VENTILATOR ASSOCIATED PNEUMONIA(VAP)
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Duration of antibiotic therapy
Timepoint
Every other day, procalcitonin is measured to determine the length of antibiotic treatment
Method of measurement
Procalcitonin Measuring Kit
Secondary outcomes
1
Description
Clinical pulmonary infection severity score
Timepoint
On admission and daily
Method of measurement
Clinical Information Collection Form
2
Description
C Reactive Protein
Timepoint
On admission then daily
Method of measurement
Clinical Information Collection Form
3
Description
Sepsis Organ Failure Assessment score
Timepoint
On admission then daily
Method of measurement
Clinical Information Collection Form
4
Description
Acute Physiologic And Chronic Health Evaluation II score
Timepoint
on addmision then daily
Method of measurement
Clinical Information Collection Form
Intervention groups
1
Description
Intervention group: after appropriate randomization drug (nebulized heparin in this group) in dose of 2 cc (10,000 heparin units) every 4 hours is given through a jet nebulizer located 30 cm in the tracheal tube at the inspiratory arm of ventilator.Other measures will be exactly the same as the recipients of standard pneumonia treatment (control group).The Heparin ampoule is supplied by the Caspian Company and is at 5000 units per cc.
Category
Treatment - Drugs
2
Description
Control group: after appropriate randomization drug (distilled water in this group) in dose of 2 cc every 4 hours is given through a jet nebulizer located 30 cm in the tracheal tube at the inspiratory arm of ventilator and standard treatment consistent of antibiotics in appropriate for the local prevalency in the ICU initially was started and then continued on the basis of culture of pulmonary secretions until the pro calcitonin serum level is in the non infected stage or at most 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Ali Ashraf
Street address
17- Shahrivar Street
City
Rasht
Province
Guilan
Postal code
4193893345
Phone
+98 13 3322 5242
Email
Draliashraf@yahoo.fr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mostafa Saeedinia
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Poursina hospital
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
mostafa.saeedinia@gmail.com
Web page address
http://www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Assistan professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
Email
aliashraf@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Assistan professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
Email
aliashraf@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect the secrets of patients and to observe ethics of study
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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