Effect of protocol-directed versus conventional-directed weaning for reducing the duration of mechanical ventilation in cardiac surgery patients who developed AKI.
comparison the effect of weaning protocol vs conventional method on the duration of mechanical ventilation in cardiac surgery patients who developed AKI
Design
Clinical trials with intervention and control group, randomized
Settings and conduct
In November 2013, Rajaie cardiovascular medical and research center adopted a mechanical ventilation weaning protocol (WM 42-05) . The study is a randomized controlled trial in which 100 patients with acute kidney injury after open heart surgery will allocate to either the protocol-directed (intervention=50) or the conventional-directed (control=50) group.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1- age 18–75 years
2- Increase in serum creatinine ≥0.3 mg/dL or urine output <0.5 ml/kg/hour for ≥4 hours
3- no previous open-heart surgery.
Exclusion criteria:
Patients who return to the operating room
Intervention groups
patient weaning from ventilator based on protocol
Main outcome variables
The duration of mechanical ventilation, creatinine and urea levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190221042783N1
Registration date:2019-06-12, 1398/03/22
Registration timing:registered_while_recruiting
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
hojjat asadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 8210
Email address
asadzadeh@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of protocol-directed versus conventional-directed weaning for reducing the duration of mechanical ventilation in cardiac surgery patients who developed AKI.
Public title
The effect of ventilator weaning protocol on duration of mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with open heart surgery
Post-operative open heart surgery patients aged between 18 and 75
Patients who have a ceratinin level of 1/5 after heart surgery
Exclusion criteria:
Cardio-pulmonary resuscitation of the patient
History of hemodialysis patient
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 Shahid Rajaee Cardiovascular Research Center
Street address
no 1, West 6, Janbazan Ave, Golbarg Blvd, Majedeyeh
City
tehran
Province
Tehran
Postal code
1333715914
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
93072
Health conditions studied
1
Description of health condition studied
Acute renal failure
ICD-10 code
N17.8
ICD-10 code description
Other acute renal failure
Primary outcomes
1
Description
Effect of weaning protocol from ventilator on mechanical ventilation time
Timepoint
Every two hours after surgery
Method of measurement
Measurement based on hours after surgery
Secondary outcomes
1
Description
The effect of protocol on the level of creatinine and blood urea
Timepoint
Every two hours after the surgery
Method of measurement
Based on hours
Intervention groups
1
Description
Intervention group: After the open heart surgery, the patients will transfer to CCU . In the Intervention group patients will separate from ventilator based on adopted mechanical ventilation weaning protocol (WM 42-05) and ventilation time will recorded. In this protocol, based on patient's readiness and considering the criteria and patient's status based on the protocol, some parameters (respiratory rate, arterial oxygen saturation, consciousness, minute volume and effective cough) will be evaluated.
Category
Treatment - Devices
2
Description
Control group: After the open heart surgery, the patients will transfer to CCU . In the control group patients will separate from ventilator based on conventional method and ventilation time will recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Cardiovascular Research Center
Full name of responsible person
Hojjat Allah Asadzadeh
Street address
No.1,West6, Janbazan Ave, Golbarg Blv,Majedeyeh
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 8849 8210
Email
asadzadeh@rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hojjat Allah Asadzadeh
Street address
No.1,West 6,Janbazan Ave, Golbarg Blvd, Majedeyeh
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 8849 8210
Email
asadzadeh59hojjat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Research Center for Shahid Rajaee Heart and Ascension