Evaluation of the correlation between serum magnesium level and lactate clearance at acute phase of sepsis
Evaluation of the correlation between intracellular magnesium level and lactate clearance at acute phase of sepsis
Design
This is a randomized, placebo-controlled and blinded clinical trial. Fifty adult patients with diagnosis of sepsis will equally be assigned to magnesium or placebo group according permuted block randomization method.
Settings and conduct
Critically ill adult patients with diagnosis of sepsis who admitted to general ICU of Imam Khomeini Hospital will be evaluated for eligibility. Fifty patients will equally be assigned to magnesium or placebo group. Patients in the magnesium group will receive magnesium sulfate as intravenous infusion to attain serum magnesium level near to 3 mg/dl. Patients in the placebo group will receive the same volume of saline. Duration of intervention is 72 hours. Medication and placebo have same packaging and appearance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Critically ill adult patients (18-65) admitted to ICU with diagnosis of sepsis will be recruited.
Exclusion criteria: Patients with hypermagnesemia [Mg]> 3.5 mg/dL, hypomagnesemia [Mg] <1.5 mg/dL, renal failure (GFR <30 ml/min /1.73 m2), moderate to severe hepatic insufficiency (child pugh score B, C), seizure , chronic alcohol consumption, malignancy, MAP <65 mm Hg resistant to vasopressors, diabetic ketoacidosis and pregnant women will be excluded.
Intervention groups
Magnesium group: Patients in this group will receive magnesium sulfate as intravenous infusion to attain serum magnesium level of 3 mg/dl as the study goal.
Control group: Patients in this group will receive placebo.
Main outcome variables
Evaluation of the effect of magnesium supplementation on lactate clearance in critically ill patients with sepsis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180410039254N1
Registration date:2018-07-11, 1397/04/20
Registration timing:registered_while_recruiting
Last update:2018-07-11, 1397/04/20
Update count:0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Afsaneh Noormandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6617 7540
Email address
a-noormandipoor@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of magnesium sulfate on lactate clearance in sepsis
Public title
Effect of magnesium sulfate on blood infection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill adult patients (18-65 years old) admitted to ICU with diagnosis of sepsis will be included.
Exclusion criteria:
Exclusion criteria: Patients with hypermagnesemia (serum magnesium level> 3.5 mg/dL, hypomagnesemia (serum magnesium level<1.5 mg/dL), renal failure (GFR <30 ml/min /1.73 m2), moderate to severe hepatic insufficiency (child pugh score B, C), seizure , chronic alcohol consumption, malignancy, MAP <65 mm Hg resistant to vasopressors, diabetic ketoacidosis and pregnant women will be excluded.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization
Unit of randomization: 4 patients in each block
Randomization tool: SAS statistical software, secured envelope
How to create a random sequence: SAS statistical software
Allocation concealment: Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Triple blinded
Blinding description
Medication and placebo are individually coded and only one patient's non-responsible nurse is aware of the codes. The medication and placebo do not differ in appearance or mode and duration of injection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.TUMS.TIPS.REC.1397.037
Health conditions studied
1
Description of health condition studied
Sepsis
ICD-10 code
A41.50
ICD-10 code description
Gram-negative sepsis, unspecified
Primary outcomes
1
Description
Lactate clearance
Timepoint
At the beginning of the study (before the intervention) and then every 6 hours on the day 0 - Day 1 - Day 2
Method of measurement
By spectrophotometry and Pars-Azmoon kit in mg/dl
2
Description
Serum magnesium level
Timepoint
At the beginning of the study (before the intervention) and then every 6 hours on the day 0 - Day 1 - Day 2
At the beginning of the study (before the intervention) and then every 6 hours on the day 0 - Day 1 - Day 2
Method of measurement
By spectrophotometry and Pars-Azmoon kit in mg/dl
Secondary outcomes
1
Description
SOFA score (Sepsis-related organ failure assessment score)
Timepoint
At the beginning of the study (before the intervention), then daily on day 0 - day 1- day 2
Method of measurement
Based on the SOFA score scale
2
Description
APACHE II score ( Acute Physiologic And Chronic Health Evaluation )
Timepoint
At the beginning of the study (before the intervention), then daily on day 0 - day 1- day 2
Method of measurement
Based on the APACHE-II score scale
3
Description
Duration of intensive care unit stay
Timepoint
Daily
Method of measurement
Count the number of hospitalization days in the intensive care unit
4
Description
Mortality
Timepoint
Daily
Method of measurement
Count the number of dead patients
Intervention groups
1
Description
Intervention group: 25 patients will be received magnesium sulfate (2 g magnesium sulfate in 50 ml of normal saline over one hour) as intravenous infusion. Infusion of magnesium sulfate will be continued to maintain serum magnesium level near 3 mg /dl for 72 hours of acute phase of sepsis.
Category
Treatment - Drugs
2
Description
Control group: 25 patients will be received 50 mL normal saline over 1 hour intravenous infusion. The rate and volume of normal serum infusion will be similar to that of the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2756
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D, PHD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D, PHD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D, PHD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript.
When the data will become available and for how long
One year after end of the study, data will be published and will be available in databases.
To whom data/document is available
َAfter permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes.
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and meta-analysis.
From where data/document is obtainable
Contact scientific responsible person for the clinical trial as needed.
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks.
Comments
Data sharing is according to permission from the sponsor.