Evaluation of the Clinical Signs and symptoms of Pneumonia Following Metoclopramide administration in unconscious patients with nasogastric tube in the intensive care unit.
1. Evaluation of the clinical signs and symptoms of pneumonia following metoclopramide administration in unconsciousness patients with nasogastric tube(NGT) in the intensive care unit (ICU)
2. Evaluation of the effect of metoclopramide on hospital stay in patients with decreased consciousness and NGT in the ICU.
3. Evaluation of the effect of metoclopramide on the number of days of antibiotic administration in patients with decreased consciousness and NGT in the ICU .
Design
clinical trial(phase 3), Randomized by balanced block randomization and controlled in two parallel groups : intervention group (n = 32) and control group (n = 32).
Settings and conduct
this study will be done in ICU of 5 hospital in Tehran; intervention group will receive tablet of metoclopramide 10 mg 3 times a day for 5 days through nasogastric tube and the control group will not receive placebo. this study will not be blinded.
Participants/Inclusion and exclusion criteria
-inclusion criteria:
1.dysphagia following the loss of consciousness,in ICU patients.
2. Nasogastric tube requirement, more than 24 hours.
-exclusion criteria:
1.esophageal disorder.
2.signs and symptoms of pneumonia
3.pregnancy and lactation.
4. history of Parkinson disease.
5.contraindication of metoclopramide.
6.drug interaction with metoclopramide.
7.gastrointestinal disorders like:GI bleeding ,obstruction ,cancer and perforation .
8.gastrointestinal surgery.
9.pheochromocytoma
Intervention groups
Patients in intervention group(n=32) will have first dose of metoclopramide intravenously, and other doses will be administered of 10 milligram( mg )metoclopramide through the NGT 3 times a day for 5 days. patients in control group wont receive placebo.
Main outcome variables
cough; sputum production; leukocytosis; abnormal signs in chest examination and chest x ray; fever; tachypnoea; hypoxia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N18
Registration date:2019-10-07, 1398/07/15
Registration timing:registered_while_recruiting
Last update:2019-10-07, 1398/07/15
Update count:0
Registration date
2019-10-07, 1398/07/15
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
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 Clinical Signs and symptoms of Pneumonia Following Metoclopramide administration in unconscious patients with nasogastric tube in the intensive care unit.
Public title
Evaluation of the Clinical Signs and symptoms of Pneumonia Following Metoclopramide administration in unconscious patients with nasogastric tube in the intensive care unit.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
dysphagia following the loss of consciousness,in ICU patients.
Nasogastric tube requirement, more than 24 hours.
Exclusion criteria:
oesophageal disorder
signs and symptoms of pneumonia
pregnancy and lactation
histoy of Parkinson disease
contraindication of metoclopramide
drug interaction with metoclopramide
gastrointestinal disorders like:GI bleeding ,obstruction ,cancer and perforation .
gastrointestinal surgery.
presence of pheochromocytoma
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
participants will be recruited to one of the two groups randomly by Balanced block randomization method ,and will receive especial intervention.
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 Islamic Azad University of Pharmaceutical Sciences
Street address
ُShahid Khaghani street(Zargandeh), Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.IAU.PS.REC.1396.182
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J69.0
ICD-10 code description
Pneumonia due to inhalation of vomit and gastric secretions
Primary outcomes
1
Description
cough incidence
Timepoint
before intervention, day 1,3 and5
Method of measurement
observational information and nursing records
2
Description
Tachypnoea (respiratory rate >25 per minute)
Timepoint
before intervention, day 1,3 and5
Method of measurement
assessment of vital signs and nursing records
3
Description
- Sputum production or oropharyngeal secretions
Timepoint
before intervention, day 1,3 and5
Method of measurement
assessment of clinical situation and nursing records.
4
Description
-Hypoxia (oxygen saturation ≤90% )
Timepoint
before intervention, day 1,3 and5
Method of measurement
puls oximeter
5
Description
-New abnormal breathing sounds in chest examination
Timepoint
before intervention, day 1,3 and5
Method of measurement
chest physical examination by stethoscope
6
Description
Fever >38 degree celsius
Timepoint
before intervention, day 1,3 and5
Method of measurement
termometer
7
Description
Leucocytosis (WBC >11 000 per Mililiter)
Timepoint
before intervention, day 1,3 and5
Method of measurement
complete blood count
8
Description
abnormal elevation of erythrocyte sedimentation rate
Timepoint
before intervention, day 1and5
Method of measurement
erythrocyte sedimentation rate test
9
Description
New chest Radiological shadowing
Timepoint
before intervention, day 3 and 5
Method of measurement
chest x ray radiography
10
Description
Leucopoenia (WBC < 3000 per Mililiter)
Timepoint
before intervention, day 1,3 and5
Method of measurement
complete blood count
11
Description
abnormal elevation of c reactive protein
Timepoint
before intervention, day 1 and 5
Method of measurement
c reactive protein test
12
Description
Symptom complex of sweating, rigors, fever, and aches and pains
Timepoint
before intervention, day 1,3 and5
Method of measurement
observational information,thermometer and critical care pain observation tool
Secondary outcomes
1
Description
counting the days that paitient stays in intensive care unit
Timepoint
from the first day of study to last day of staying patient in the intensive care unit
Method of measurement
assessment of the patients medical records
2
Description
Number of antibiotic therapy days
Timepoint
from the first day of study to last day of staying patient in the intensive care unit
Method of measurement
assessment of the patients medical records
3
Description
Highest white blood cells count in millimeter cube
Timepoint
daily from the first day to 5th day
Method of measurement
complete blood count
4
Description
Highest C reactive protein( milligram per deciliter)
Timepoint
first day and 5th day of study
Method of measurement
c reactive protein assessment test
5
Description
Lowest oxygen saturation percent
Timepoint
daily from the first day to 5th day of study
Method of measurement
puls oxymeter
6
Description
Mortality at 30 days
Timepoint
from the first day of study to 30th day
Method of measurement
assessment of medical records
7
Description
Regurgitation through Nasogastric tube
Timepoint
daily from the first day to 5th day of study
Method of measurement
observational assessment of patients situation
Intervention groups
1
Description
Intervention group: patient receives metoclopramide 10 milligram -three times a day for 5 days.first dose prescribe in form of ampul and should be used from intravenous route.the other doses prescribe in form of tablet and should be used in route of gavage.
Category
Prevention
2
Description
Control group: patients in this group dont receive any drug or interventio n and we just monitor them .
opposite of islamic azad university, university square, end of the north sattari highway
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7151
Fax
Email
sheydakh@ymail.com
Web page address
http://farhikhtegan.iautmu.ac.ir/fa
3
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Sheyda Khosravi
Street address
opposite of Sardar Jangal garden,Shirmohammadi street,NaziAbad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 2662
Fax
Email
sheydakh@ymail.com
Web page address
http://amhos.iautmu.ac.ir/fa
4
Recruitment center
Name of recruitment center
Ghiasi hospital
Full name of responsible person
Sheyda Khosravi
Street address
Shahid Soleimani street, Shahid Banaee street, after Yaft Abad crossroad, Ayatollah Saeedi highway
City
Tehran
Province
Tehran
Postal code
1373658153
Phone
+98 21 6621 0101
Email
sheydakh@ymail.com
Web page address
http://ghiassihospital.com
5
Recruitment center
Name of recruitment center
Pasargad hospital
Full name of responsible person
Sheyda Khosravi
Street address
No. 132, facing Taherian(Amol) sreet, between Taleghani street and Somayeh street, Shariati street
City
Tehran
Province
Tehran
Postal code
1561937114
Phone
+98 21 7760 1053
Fax
+98 21 7762 2244
Email
sheydakh@ymail.com
Web page address
http://pasargadgeneralhospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Pharmaceutical Science
Full name of responsible person
Farshad Hashemian
Street address
#99, Yakhchal Ave, Shariati st.
City
tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
Sheydakh@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Pharmaceutical Science
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mehdi Rajabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
mehdirj@aol.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rajabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati street , Yakhchak street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
mehdirj@aol.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sheyda Khosravi
Position
Pharmacy Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal street , Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
sheydakh@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
Information about the primary outcome will be shared after Deidentification of Individual Participant Data
When the data will become available and for how long
after publication of paper,for two years
To whom data/document is available
Academic persons
Under which criteria data/document could be used
Academic or clinical use. users should cite the primary document
From where data/document is obtainable
via email to corresponding author
What processes are involved for a request to access data/document
Submition of valid and formal documentation of affiliation to the Academic Center, Explaination about how to use the information and the purpose of request