Purpose: Clinical trial effect of intravenous lipid emulsion on improve cardiac function after open heart surgery. A total of 60 patients who underwent open heart surgery and in the ICU were hospitalized to be chosen and a double blind (Researchers and patients were unaware of the drugs) randomized using a random number table is divided into two groups. The patient in group 1 was injected normal saline (500cc) and in group 2 was injected intravenous lipid (500cc) (construction company Frezenius) emulsion 20%. During the 3-hour infusion of both solutions at 1cc /kg /h, then (EF) Ejection Fraction was measured. Inclusion criteria: Candidate for CABG surgery; consent to participate in research; The first surgery of CABG; Ef above 35 ; BMI less than 30 ; lack of familial metabolic disorder; no need for mechanical ventilation and inotrope
Exclusion criteria: re-heart surgery; need to balloon pump; rate disorder during surgery and then. Primary outcome: improved heart function using echo devices before surgery and after surgery were evaluated.
Secondary outcome: stay in the intensive care unit of admission in ICU after surgery until discharge or transfer to the criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092412094N5
Registration date:2017-01-31, 1395/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Majid Razavi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8630
Email address
razavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-12-11, 1393/09/20
Expected recruitment end date
2015-05-11, 1394/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intravenous lipid emulsion on improve cardiac function after open heart surgery
Public title
Clinical trial effect of intravenous lipid emulsion on improve cardiac function after open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for CABG surgery; consent to participate in research; The first surgery of CABG; EF above 35 ; BMI less than 30 ; lack of familial metabolic disorder; no need for mechanical ventilation and inotrope
Exclusion criteria: re-heart surgery; need to balloon pump; rate disorder during surgery and then
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
IR.MUMS.REC.1393.193
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Ejection Fraction
Timepoint
Before and after surgery
Method of measurement
Echocardiography device
Secondary outcomes
1
Description
Stay in intensive care units
Timepoint
Since admission to the ICU after surgery until discharge or transfer to the
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: injected 500cc intravenous lipid (construction company Frezenius) emulsion 20% injected during the 3 hours at 1cc/kg/h.
Category
Treatment - Drugs
2
Description
Control group: Patients received 500 cc normal saline during the 3-hours at 1cc /kg /h
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Majid Razavi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Razavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Razavim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Razavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Razavim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Daghestani
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Mashhaf
Postal code
Phone
+98 51 3802 2711
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)