Protocol summary

Summary
Objective: Evaluation the effect of nebulized heparin in improvement of lung function in patients expected to require prolonged mechanical ventilation. Design: Non-randomized controlled clinical trial. Setting: Mechanically ventilated patients hospitalized at intensive care unit of Alzahra hospital affiliated to Isfahan University of Medical Sciences. Major Inclusion and Exclusion criteria: Patients who require invasive mechanical ventilation for more than 48 hours will be enrolled in the study. If patients receive mechanical ventilation for more than 24 hours prior to enrollment, require mechanical ventilation for more than 48 hours in a previous admission to the ICU during the current hospital admission, allergy to heparin (including any history of heparin-induced thrombocytopenia), a pulmonary hemorrhage in the previous 3 months, uncontrolled bleeding or a significant bleeding disorder, an intracranial hemorrhage in the past 12 months, or an epidural catheter in place or likely to be placed in the next 48 hours and are younger than 18 years old will be excluded. Intervention: Patients in drug group will receive heparin 10000 Iu every 6 hours via nebulization for 5 days. Both groups will receive all other standard treatments. Main outcome measures: the average daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2) while the patient remained ventilated during 5 days of treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701011497N6
Registration date: 2017-01-18, 1395/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the anti-inflammatory effects of nebulized heparin in ventilator-induced lung injury
Public title
Investigation of the anti-inflammatory effects of heparin in mechanically ventilated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who require invasive mechanical ventilation for more than 48 hours. Exclusion criteria:If patients receive mechanical ventilation for more than 24 hours prior to enrollment; has required mechanical ventilation for more than 48 hours in previous admission in ICU during the current hospital admission; allergy to heparin (including any history of heparin-induced thrombocytopenia); a pulmonary hemorrhage in the previous 3 months; uncontrolled bleeding or a significant bleeding disorder; an intracranial hemorrhage in the past 12 months; or an epidural catheter in place or likely to be placed in the next 48 hours and are younger than 18 years old.
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2015-09-05, 1394/06/14
Ethics committee reference number
2611/4/د

Health conditions studied

1

Description of health condition studied
Mechanical Ventilation
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders

Primary outcomes

1

Description
Changes in ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2)
Timepoint
during the 5 days of study
Method of measurement
ratio of PaO2/FiO2

Secondary outcomes

1

Description
(RSBI)RAPID SHALLOW BREATHING INDEX
Timepoint
during 5 days of study
Method of measurement
ratio of tidal volume to respiratory rate

Intervention groups

1

Description
Intervention group: Patients in drug group will receive heparin 10000 Iu every 6 hours via nebulization for 5 days. Both groups will receive all other standard treatments
Category
Treatment - Drugs

2

Description
Control group: Patients will receive standard treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sarah Mousavi
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Alzahra Hospital
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
1209/4/12/پ
Grant code / Reference number
194043
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue, Isfahan University of Medical Science, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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