determination of the effects of hypothermia on electrolyte changes in adult patients undergoing open heart surgery
Design
a clinical trial with control group, parallel groups, single blinded, made as accident using a random number table, sample size of a whole of sixty people of whom 30 people were put in each group.
Settings and conduct
the study was done in Sari Fateme Zahra Hospital. all the patient's were operated on by a heart surgeon. after obtaining informed consent the patients were randomly put in the two groups of hypothermia and normothermia without knowledge of which group they were put in. in the hypothermia group the patient's body temperature is brought down to 30°c, in the normothermia group the patient's body temperature naturally comes down to 35° c. the blood sodium, potassium, and calcium levels were measured and recorded in the preoperative stages, one day after the operation and the day of ICU discharge.
Participants/Inclusion and exclusion criteria
Entry conditions : adult patients of ages 40 to 85; being eager to study; residence in mazandaran; lack of psychological disorders
Exit conditions : usage of depression drugs; a lack of interest in going on with the study; valve replacement at the same time as CABG; people in need of emergency surgery
Intervention groups
in the hypothermia group the patient's body temperature is brought down to 30°c and topical cooling is also used.
in the normothermia group the patient's body temperature naturally comes down to 35°c.
Main outcome variables
any electrolyte disturbances of too high or too low of sodium(135 to 145 mEq/L) are known as hyponatremy and hypernatremy . electrolyte disturbances of too high or too low of potassium(3/5 to 5/5 mEq/L) are known as hypokalemia and hyperkalemia. electrolyte disturbances of too high or too low of calcium(8/5 to 10/2 mEq/L) are known as hypocalcaemia and hypercalcaemia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190719044273N1
Registration date:2019-09-03, 1398/06/12
Registration timing:retrospective
Last update:2019-09-03, 1398/06/12
Update count:0
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Hodeise Asadpour sorkhkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 4731
Email address
hodeiseasadpour1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2019-06-18, 1398/03/28
Actual recruitment end date
2019-08-11, 1398/05/20
Trial completion date
2019-08-11, 1398/05/20
Scientific title
The effect of hypothermia on electrolyte changes in adult patients undergoing open heart surgery
Public title
The effect of hypothermia on electrolyte changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients of ages 40 to 85
Being eager to study
Residence in mazandaran
Lack of psychological disorders
Exclusion criteria:
Usage of depression drugs
A lack of interest in going on with the study
Valve replacement at the same time as CABG
People in need of emergency surgery
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were taken by the availability method, and all the patients who met the conditions of the study were picked, samples were taken of two groups of hypothermia and normothermia randomly chosen patients by using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
After explaining the study and obtaining informed consent from the participants, they were not informed of the group they were put in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sari University of Medical Sciences
Street address
Next to 13aban pharmacy, MOallem sq
City
Sari
Province
Mazandaran
Postal code
4843161399
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.MAZUMS.REC.1398.575
Health conditions studied
1
Description of health condition studied
Coronary heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
any electrolyte disturbances of too high or too low of sodium(135 to 145 milliequivalent per liters) are in order known and registered as electrolyte hyponatremy and hypernatremy disturbances.
Timepoint
measurements were taken at times before surgery, one day after surgery and the day of discharge from ICU
Method of measurement
a study of blood samples in the lab
2
Description
any electrolyte disturbances of too high or too low of potassium(3/5 to 5/5 milliequivalent per liters) are in order known and registered as electrolyte hypokalemia and hyperkalemia disturbances.
Timepoint
measurements were taken at times before surgery, one day after surgery and the day of discharge from ICU
Method of measurement
a study of blood samples in the lab
3
Description
any electrolyte disturbances of too high or too low of calcium(8/5 to 10/2 milliequivalent per liters) are in order known and registered as electrolyte hypocalcaemia and hypercalcaemia disturbances.
Timepoint
measurements were taken at times before surgery, one day after surgery and the day of discharge from ICU
Method of measurement
a study of blood samples in the lab
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the hypothermia group the patient's body temperature is brought down to 30°c and topical cooling is also used.
Category
Treatment - Other
2
Description
Control group: in the normothermia group the patient's body temperature naturally comes down to 35°c.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra hospital
Full name of responsible person
Soleiman MOslemipour
Street address
Next to Sari blood transfusion center, Artesh Blvd., Emam Hossein Sq.
City
Sari
Province
Mazandaran
Postal code
13371-48188
Phone
+98 11 3332 3024
Email
Hodeiseasadpour1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Payambare Azam academic center, Khazarabad Ave., Khazar sq.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3082
Email
Majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?