Evaluation of the effect of HemoHIM supplement for the prevention of ventilator associated pneumonia in critically ill patients
Design
A randomized, controlled clinical trial with parallel groups was designed among 30 patients (15 patients in each HemoHIM and control groups). Restricted randomization with permuted block method by computer was used to allocate patients to these 2 groups.
Settings and conduct
This randomized clinical trial was designed to evaluate the HemoHIM supplement's effect for preventing ventilator-associated pneumonia among 30 patients admitted to the intensive care unit of Kashani hospital in Isfahan, Iran, in two parallel groups. After gaining informed consent patients are allocated to HemoHIM and control group based on restricted randomization with permuted block method. In the intervention group, in addition to standard prevention strategies, a packet of HemoHIM supplement is used daily and orally for 7 days. But, in the control group, only standard prevention strategies were conducted. All patients were followed daily to ventilator-associated pneumonia based on clinical pulmonary infection score (CPIS) criteria for 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gaining informed consent, adult patients undergoing mechanical ventilation for more than 48 hours.
Exclusion criteria: Diagnosis of acute respiratory distress syndrome or pneumonia at intensive care unit (ICU) admission; Existence of immunodeficiency and leukopenia
Intervention groups
Intervention group: In addition to standard prevention strategies, a packet of HemoHIM supplement containing 20 cc of herbal extract is used daily and orally for 7 days.
Control group: Only standard prevention strategies were conducted.
Main outcome variables
Incidence of ventilator-associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N6
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Shadi Farsaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2618
Email address
farsaei@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of HemoHIM supplement for the prevention of ventilator associated pneumonia in critically ill patients
Public title
The effect of HemoHIM supplement for the prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gaining informed consent
Adult patients undergoing mechanical ventilation for more than 48 hours
Exclusion criteria:
Diagnosis of acute respiratory distress syndrome or pneumonia at intensive care unit (ICU) admission
Existence of immunodeficiency and leukopenia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization with the permuted block method was used to create the random sequence and balance the number of allocated samples in each group (control and HemoHIM). The computer program was used for a random sequence in blocks of 2, 4, and 6. Each block has an equal number of control and HemoHIM groups. It is written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group.
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
Bldg No. 4, Isfahan University of Medical Sciences and Health Services, Hizar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.767
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Incidence of ventilator associated pneumonia
Timepoint
Evaluation of the occurrence of ventilator associated pneumonia daily, during 14 days after study recruitment
Method of measurement
Calculate the clinical pulmonary infection score (CPIS) table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the standard care conducted in ICU for preventing ventilator-associated pneumonia, a packet of HemoHIM supplement containing 20 cc of herbal extract manufactured by KolmarBNH Sun Biotech Business (SBT) company of Korea is used daily and orally for 7 days.
Category
Prevention
2
Description
Control group: Receive standard care of the intensive care unit to prevent ventilator-associated pneumonia, such as head elevation