Effect of Intravenous Phosphorus in Comparison to Oral Phosphate for Treatment of hypophosphatemia in Critically ill Patients
Design
Clinical trial with 2 groups: First group with oral therapeutic phosphate and second group with intravenous therapeutic phosphorus, Community based and pragmati, with a parallel group design of 140 patients, Randomised
Settings and conduct
This clinical trial study is carried out at the Masih Daneshvari Hospital. Among all patients over the age of 18 admitted to the ICU, we selected patients with hypophosphatemia according to the number of selected samples and randomly divided into two groups. One group is treated with oral phosphate and the other is treated with intravenous phosphorus.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient over 18 years old ;Admitted to Intensive Care Unit
Exclusion criteria: The patient needs renal replacement therapy The patient that has a serum potassium concentration greater than 5 m.mol / L. Patient without basic phosphate level Chronic kidney failure with and without dialysis
Intervention groups
Patient with hypophosphatemia treatment with oral phosphate and intravenous phosphorus
Main outcome variables
Oral phosphate and intravenous phosphrus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N18
Registration date:2018-05-29, 1397/03/08
Registration timing:retrospective
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous Phosphorus in Comparison to Oral Phosphate for Treatment of hypophosphatemia in Critically ill Patients
Public title
Comparison intravenous Phosphorus to Oral Phosphate for Treatment of hypophosphatemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient over 18 years old
Admitted to Intensive Care Unit
Exclusion criteria:
The patient needs renal replacement therapy
The patient that has a serum potassium concentration greater than 5 m.mol / L.
Patient without basic phosphate level
Chronic kidney failure with and without dialysis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The groups randomization will performed based on the A and B allocation group. This process will managed by computerizing allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.SBMU.MSP.REC.1396.111
Health conditions studied
1
Description of health condition studied
Disorders of phosphorus metabolism and phosphatases
ICD-10 code
E83.3
ICD-10 code description
Disorders of phosphorus metabolism and phosphatases
Primary outcomes
1
Description
Phosphor level
Timepoint
Before & After intervention
Method of measurement
Before intervention and 3 days after intervention
Secondary outcomes
1
Description
Compensation of hypophosphatemia
Timepoint
Before & After intervention
Method of measurement
Before intervention and 3 days after intervention
2
Description
Duration of stay in ICU
Timepoint
From the time of admission to the exit from the ICU
Method of measurement
Number of hospital days in ICU
Intervention groups
1
Description
Intervention group: Patients with hypophosphatemia receiving oral phosphate.
Category
Treatment - Drugs
2
Description
Intervention group: Patients with hypophosphatemia receiving intravenous phosphorus
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Dr. Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Masih Daneshvari Hospital
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
The Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohammadreza Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2111 9279
Email
iran.criticalcare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohammad Reza Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2111 9279
Email
iran.criticalcare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Edjucational , Research and Treatment center
Full name of responsible person
Somayeh Akhavan
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
somayehakhavan30@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available