Protocol summary

Summary
The aim of this study was to evaluate the effect of intravenous fluid with ISO tonic and hypo tonic fluids on biochemical parameters of patients who were admitted in intensive care unit of Imam Sajad hospital and Behest i hospital,Yasuj, Iran in 2017. Patients over 18 years; patients who have not baseline electrolyte imbalance; were enrolled. And patients with chronic renal and heart failure; patients who have taken diuretics; patients with acute or chronic neurological disorder; patients who take sodium bicarbonate; were excluded. This clinical trial is conducted on 64 patients. Patients were NP O for at least 48 hours and vital signs and urine output were measured. Patients were randomly assigned (1.1 ratio) in to two groups and one group received normal saline and the other group received half saline. For all patients before and after treatment glucose-creation-urea-potassium-sodium-blood gases and urine specific gravity were measured and compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101522869N5
Registration date: 2017-11-16, 1396/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Science
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous fluid therapy with ISO tonic and hypo tonic fluids ( saline ./45%) on biochemical parameters of admitted patients to Intensive care unit
Public title
Effect of intravenous fluid therapy with ISO tonic and hypo tonic fluids on biochemical parameters of patients who was admitted in intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age> 18 years; absence of electrolyte imbalance before the study; absence of brain damage (tumor-ischemia-bleeding and etc.). Exclusion criteria: Serum sodium <133 or>145 on admission ; patients with chronic renal failure; patients with chronic heart failure; patients who were admitted with increased blood pressure; patients who have taken diuretics; patients with edema; patients with abnormalities of the adrenal gland; patients with acute or chronic neurological disorder; Patients who take sodium bicarbonate.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Science
Street address
Yasuj University of Medical Science, Motahari street, Yasuj city
City
Yasuj
Postal code
75917-41417
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.YUMS.REC.1396.37

Health conditions studied

1

Description of health condition studied
electrolyte imbalance
ICD-10 code
E87.1
ICD-10 code description
Hypo-osmolality and hyponatraemia

Primary outcomes

1

Description
plasma sodium
Timepoint
48
Method of measurement
flame emission photometry

Secondary outcomes

1

Description
Hyponatremia
Timepoint
48
Method of measurement
Flame emission photometry

Intervention groups

1

Description
Patients received intravenous ISO tonic fluid
Category
Treatment - Drugs

2

Description
Patients received intravenous hypotonic fluid
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
intensiv care unit of Emam sajad and Beheshti hospital
Full name of responsible person
Moslem Sedaghattalb
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Street address
Motahari street, Yasuj city Yasuj
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
moslem Sedaghattalab
Position
Assiatant professor
Other areas of specialty/work
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city Yasuj
City
Yasuj
Postal code
75917-41417
Phone
+98 74 3322 0163
Fax
Email
m.sedaghattalab@yums.ac.ir; moslem.sedaghattalab@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Moslem Sedaghattalab
Position
Assiatant professor
Other areas of specialty/work
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city Yasuj
City
Yasuj
Postal code
75917-41417
Phone
+98 74 3322 0163
Fax
Email
m.sedaghattalab@yums.ac.ir; moslem.sedaghattalab@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city
City
Yasuj
Postal code
75917-41417
Phone
+98 74 3322 0163
Fax
Email
m.sedaghattalab@yums.ac.ir; moslem.sedaghattalab@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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