A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscopy on outcome of severe lung contusion in patients admitted to intensive care unit (ICU)
A comparison of two stem cells utilization methods including intravenous and intra-alveolar infiltration on outcome of severe lung contusion in patients admitted to intensive care unit (ICU)
Design
A clinical trial with a control group and two intervention groups, with parallel groups, single-blind, randomized, phase 2 on 30 patients. R statistical software is used for block randomization.
Settings and conduct
This clinical trial, is performed on 30 patients with severe hypoxia requiring mechanical ventilation and admitted to the ICU during the first 24 hours at Shahid Bahoner Hospital, Kerman. It is a single-blind study, so that the results are determined by uninformed anesthesiologist, nurse, and laboratory personnel.
Participants/Inclusion and exclusion criteria
Inclusion criteria: arterial oxygen pressure to inspiratory oxygen less than 180; bilateral infiltration with pulmonary edema; pulmonary contusion more than 40%; need to ICU admission; age between 18 and 65 years.
Non-inclusion criteria: pregnant or lactating women; active malignancy; mortality probability more than 50% in the next six months; moderate to severe liver disorder; severe chronic lung disease; lung transplant
Intervention groups
Intervention group 1: will be injected with 60 million dental pulp stem cells intravenously; Intervention group 2: will be pushed dental pulp stem cells inside the Alveolus by bronchoscope; Intervention group 3: will only receive the usual treatments.
Main outcome variables
Arterial to inspiratory oxygen pressure ratio؛ ventilation duration؛ death؛length of ICU hospitalization؛ need for intubation؛ forced vital capacity(FVC)؛ forced expiratory volume in one second to FVC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101220005426N12
Registration date:2022-10-29, 1401/08/07
Registration timing:prospective
Last update:2022-10-29, 1401/08/07
Update count:0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscopy on outcome of severe lung contusion in patients admitted to intensive care unit (ICU)
Public title
A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscope on outcome of severe lung contusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The pressure of arterial oxygen to inspiratory oxygen should be less than 180(PaO2/FIO2<180)
Bilateral infiltration with pulmonary edema in anterior lung radiography
Pulmonary contusion greater than 40% in chest CT scan
The need to transfer to the intensive care unit due to respiratory failure
Criteria 1-4 must all be present within a 24-hour period at the time of study entry
Exclusion criteria:
More than 96 hours have passed since the patient's ARDS trauma
Pregnant or lactating woman
Presence of any active malignancy (other than nonmelanoma skin cancer) that requires treatment within 2 years
Any irreversible disease such as malignancies and a condition with a 50% chance of death within the next six months
Moderate to severe liver disorder based on Child-Puff criteria<12
chronic obstructive pulmonary disease(COPD)
The patient has undergone a lung transplant
The patient's lack of consent, or if the patient is unable to answer, the patient's guardian's lack of consent
A patient who is not expected to be alive in the next 24 hours according to the Apache criteria
Class III or IV pulmonary hypertension
Pulmonary embolism or deep vein thrombosis in the past three months
Brain trauma
Transfusion of large volume of blood (injection of more than 10 units of blood in the last 24 hours)
The presence of heart failure, kidney and diabetes
Patients in a state of shock and previous concurrent contusion
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize people to three groups, the block randomization method is used in such a way that blocks of size 6 are used. R statistical software is used for random block allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
It is a one-way blind method in which stem cells are injected by an ICU specialist. Examination of pneumonia (CPIS criteria, clinical history, clinical examination and chest x-ray) will be done by an anesthesiologist, and the arterial oxygen pressure will be checked by the senior ICU nurse who does not know the type of cell injection to the patients. Also, laboratory tests will be done by a technician who's not aware of the interventions will be made
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.KMU.REC.1401.128
Health conditions studied
1
Description of health condition studied
lung contusion
ICD-10 code
S27.32
ICD-10 code description
Contusion of lung
Primary outcomes
1
Description
Arterial oxygen pressure to inspiratory oxygen pressure ratio
Timepoint
The ratio of arterial oxygen pressure to inspiratory oxygen pressure at the beginning of the study (before the start of the intervention) and 1, 4 and 10 days after cell injection in intervention and control groups
Method of measurement
ABG
2
Description
Average duration (days) of ventilation
Timepoint
After the intervention, daily until the end of hospitalization
Method of measurement
check list
3
Description
death
Timepoint
death between 28 and 60 days after the start of the study
Method of measurement
Check list
4
Description
Average period of stay in ICU
Timepoint
The average period of stay in the ICU between 28 and 60 days after the start of the study in the intervention and control groups
Method of measurement
check list
5
Description
Need for intubation
Timepoint
Need for intubation during the study
Method of measurement
Check list
6
Description
forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC)
Timepoint
forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC) at the 1, 3 and 6 months after the start of study in intervention and control groups
Method of measurement
spirometry
7
Description
Forced vital capacity
Timepoint
Forced vital capacity at the 1, 3 and 6 months after the start of study in intervention and control groups
Method of measurement
spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first group will receive 60 million dental pulp stem cells intravenously in addition to common supportive treatments
Category
Treatment - Other
2
Description
Intervention group 2: The second group, in addition to common supportive treatments, 60 million dental pulp stem cells are pushed by a bronchoscope inside the lung alveoli in the contusion area (based on CT scan findings).
Category
Treatment - Other
3
Description
Control group: They will only be treated by usual treatments