Evaluation of the Serum Potassium Level in Different Modalities of Intravenous Potassium Infusion on Correction of Hypokalemia in Critically Ill Patients
Design
Single blinded randomized clinical trial
Settings and conduct
The patient, the person preparing the medication, and the person doing the blood sampling are not blinded, and only the researcher who places the patients in the study groups from the randomization table is blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20 to 75 years ,Hospitalization in intensive care unit with blood potassium .
Exclusion criteria: Heart disease, kidney disease, Diabetes, High blood pressure ,Gastrointestinal inflammatory disease ,Diarrhea and vomiting, Taking Inotrops.
Intervention groups
Intervention group one : Administration of 20 mEq of potassium chloride as infusion over one hour .
Intervention group two: Administration of 20 mEq of potassium chloride by infusion over three hours .
Main outcome variables
Serum potassium level, arrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N102
Registration date:2020-09-22, 1399/07/01
Registration timing:prospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of two methods of intravenous potassium infusion on the correction of hypokalemia in Critically Ill Patients
Public title
Evaluation of two methods of intravenous potassium infusion on the correction of hypokalemia in Critically Ill Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 75 years
Hospitalization in intensive care unit with blood potassium level 3.5-2.5
Exclusion criteria:
Heart disease
kidney disease
Diabetes
High blood pressure
Gastrointestinal inflammatory disease
Diarrhea and vomiting
Taking diuretics
Potassium supplementation
ACEI Consumption
Bicarbonate
Cardiac arrhythmia
Use of inotropic drugs
Acid and base disorder
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups of 32, using the table from www.randomization.org.Patients are divided into groups A and B at the arrival to the intensive care unit and treated according to their group
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient, the person preparing the medication, and the person doing the blood sampling are not blinded, and only the researcher who places the patients in the study groups from the randomization table is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.SUMS.MED.REC.1399.31
Health conditions studied
1
Description of health condition studied
Hypokalemia
ICD-10 code
E87.6
ICD-10 code description
Hypokalemia
Primary outcomes
1
Description
Correction of blood potassium levels in patients with hypokalemia with 3-hour potassium infusion
Timepoint
A blood sample is taken from the patient to check the blood level of potassium1 hour, 3 hours and 6 hours after the end of the infusion,
Method of measurement
A blood sample
Secondary outcomes
1
Description
Arrhythmia
Timepoint
1 hour, 3 hours and 6 hours after the end of the infusion,
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group:Administration of 20 mEq of potassium chloride as infusion over one hour
Category
Treatment - Drugs
2
Description
Intervention group:Administration of 20 mEq of potassium chloride by infusion over three hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Neda Zeinali
Street address
Namazi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
nedaznl68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Zeinali
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
nedaznl68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mansoor Masjedi
Position
Intensivist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mansoormasjedi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD