Investigating the effect of magnesium sulfate loading dose on diabetic ketoacidosis patients
Design
A single-blind, randomized clinical trial study with parallel groups and phases 3 on 50 patients. Randomization will be done by block randomization method using Random allocation software.
Settings and conduct
This clinical trial study will be conducted on 50 patients with diabetic ketoacidosis admitted in Urmia Imam Khomeini Hospital. The patient will be blind about his/her allocation into intervention or placebo groups.
Participants/Inclusion and exclusion criteria
In this study, 50 patients with diabetic ketoacidosis and aged 14 to 65 years will be included. Patients with hypermagnesemia (magnesium more than 3 mg/dL), hypomagnesemia (magnesium less than 1.5 mg/dL), and sever renal failure (GFR < 30 ml/min/1.73 m2) will be excluded.
Intervention groups
For patients in the intervention group, magnesium sulfate will be injected as a loading dose (4 grams of magnesium sulfate equivalent to 8 ml from a vial of 50% magnesium sulfate). This amount of magnesium is diluted with 0.9% saline solution to a volume of 250 ml and will be infused within 4 hours for two consecutive days. Patients in the control group will receive saline 0.9% with the same volume in 4 hours.
Main outcome variables
Prescribed total dose of insulin and potassium; The length of time it will take time to convert insulin administration from IV to subcutaneous form and recovery time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220928056051N3
Registration date:2023-04-26, 1402/02/06
Registration timing:prospective
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Laya Hooshmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
hooshmand.l@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of magnesium sulfate loading dose on diabetic ketoacidosis patients
Public title
The effect of magnesium sulfate loading dose in treatment of diabetic ketoacidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic ketoacidosis
Age between 14-65 years
Exclusion criteria:
Hypermagnesemia (magnesium more than 3 mg/dL)
Hypomagnesemia (magnesium less than 1.5 mg/dL)
Having clinical symptoms of hypermagnesemia including neuromuscular symptoms (loss of deep tendon reflexes, muscle paralysis, apnea) and cardiovascular symptoms
Severe renal failure (GFR < 30 ml/min/1.73 m2)
Patients with drug poisoning
Pregnancy
Age
From 14 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be implemented. Patients will be allocated to intervention or control groups based on generated numbers. According to the total sample size (50 patients), 13 blocks of 4 will be considered. (A: intervention group and B: control group). So that the all possible combinations of ABAB will be listed. Then the randomization based on generated computer numbers will continue until all patients are allocated in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be conducted as a single-blind clinical trial. The patient will be blind of his/her allocation into intervention or placebo groups. Magnesium sulfate and placebo vials will be similar in color, shape, and size.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences
Diabetes mellitus due to underlying condition with ketoacidosis
Primary outcomes
1
Description
The total dose of prescribed insulin until the patient exits from acute phase of diabetic ketoacidosis
Timepoint
Daily until the third day after the intervention
Method of measurement
Vial
2
Description
The total dose of prescribed potassium until the patient exits from acute phase of diabetic ketoacidosis
Timepoint
Daily until the third day after the intervention
Method of measurement
Vial
3
Description
The length of time it will take time to convert insulin administration from IV to subcutaneous form
Timepoint
Until the third day after the intervention
Method of measurement
Clock
Secondary outcomes
1
Description
Prolonged time for patient recovery from acute phase of diabetic ketoacidosis
Timepoint
Until the third day after the intervention
Method of measurement
Clock
2
Description
Serum magnesium
Timepoint
Before and daily until the third day after the intervention
Method of measurement
Blood test
3
Description
Fasting blood sugar
Timepoint
Before and daily until the third day after the intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: For patients in the intervention group, magnesium sulfate will be injected as a loading dose (4 grams of magnesium sulfate equivalent to 8 ml from a vial of 50% magnesium sulfate). This amount of magnesium is diluted with 0.9% saline solution to a volume of 250 ml and will be infused within 4 hours for two consecutive days.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will receive 0.9% saline with a volume of 250 ml within 4 hours.