Protocol summary

Summary
Traditionally, maintenance fluid replacement in children about 50 years ago based on Holliday Segar liquid formula Hypotonic used. In recent years, studies have shown that the use of Hypothonic liquid can Hyponatremia some children due to fluid therapy. In some cases, Hyponatremia can lead to irreversible neurological symptoms and even death. Hypothonic ( serum containing 30 meq/lit in children under 12 months, containing 50 meq/lit children over 12 months ) with intravenous fluid contains high levels of sodium ( serum containing 50 meq/lit in children under 12 months and children over 12 months liquid 100meq.lit ), on admission and 24 hours after starting rehydration, compared to volume urine in children receiving intravenous fluid Hypothonic with intravenous fluid contains high levels of sodium, on admission and 24 hours after starting rehydration compared blood pressure changes in children receiving intravenous fluid Hypothonic with intravenous fluid contains high levels of sodium, on admission and 24 hours after starting rehydration compared the prevalence of hypernatremia , Hyponatremia (serum sodium level greater than 135 - 145 ) in both fluids. Inclusion criteria: children in age from 30 days to 14 years without speaking to him prescribe intravenous fluid for at least 24 hours in the ICU Bahrami Children Hospital, Tehran University of Medical users are admitted. Exclusion criteria: patients with acute or chronic renal parenchymal; patients at risk of cerebral edema; diabetic ketoacidosis; head trauma; heart disease; patients Hypoglycemia; patients with abnormal secretion of antidiuretic hormone; diabetes insipidus disorders; pituitary or hypothalamic; patients underwent surgery to have lost a lot of blood during surgery; patients after surgery of cranial or thorax; cirrhotic patients; patients with severe malnutrition; diabetes; any disease that his doctors do not accept this fluid. Withdrawal criteria: children with higher serum sodium lower than the normal range (135_145); would be required CPR; intubation; death, early oral feeding, any conditions that the patient's physician his decision to withdraw from the study or decide to change intravenous fluids. In the beginning especially sodium levels, blood pressure and urine specific gravity will be check and again 24 hours after initiation of intravenous fluid to be re- check. Liquid sodium 50 and 100 mEq per liter of liquid will be used. Fluid besides sodium respectively containing potassium of 20 mEq per liter of liquid glucose to a concentration of 10 grams per liter. Fluid volume shall be calculated according to the formula Holliday _ segar , so go for one weighing 10 kg and 10 kg weight Kg 100 cc per second per Kg weight of 50 cc and 20 cc per kg body weight remaining Kg weight may be given intravenous fluid every 24 hours . Finally, the groups are compared in terms of average plasma sodium. The specific gravity of the urine and blood pressure before and after receiving IV therapy is evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121015740N1
Registration date: 2014-05-04, 1393/02/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-04, 1393/02/14
Registrant information
Name
Motahare Aghajani Delavar
Name of organization / entity
Tehran Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 2447
Email address
maghajani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2014-01-04, 1392/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of intravenous fluid with different concentrations of sodium on serum sodium levels in patients admitted to the intensive care unit of Bahrami Children's Hospital in 2012-13.
Public title
Effect of intravenous fluid sodium concentration on plasma sodium in pediatric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children in the age range 30 days to 14 years for his doctor prescribe intravenous fluid and pain for at least 24 hours in hospital pediatric intensive care Bahrami,Tehran University of Medical are admitted users. Exclusion criteria: patients with acute or chronic renal parenchymal problems, such as diabetic ketoacidosis and cerebral edema in patients at risk of trauma to the head, heart disease; hypoglycemic patients; patients with abnormal secretion of antidiuretic hormone; diabetes insipidus; pituitary or hypothalamic disorders. patients underwent surgery to have lost a lot of blood during surgery, and cranial thoracic surgery patients; cirrhotic patients; patients with severe malnutrition; diabetes, and his doctor to his patient fluid therapy in a framework designed this study can not reject. Withdrawal criteria; The research indicates that children with higher serum sodium lower than the normal range (135_145); the need to take CPR; being intubated; the death; early oral feeding; or any condition that a doctor's decision to withdraw his case if the study or decide to change intravenous fluids may be excluded.
Age
From 1 year old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Medical Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz st.Ghods st.
City
Tehran
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
3480/130د/91

Health conditions studied

1

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

Primary outcomes

1

Description
Plasma concentrations of sodium
Timepoint
24 hours after initiation of intravenous fluid
Method of measurement
Sodium concentration in the blood sample

Secondary outcomes

1

Description
Complications Haypvnatrmy
Timepoint
During and after reading
Method of measurement
Clinical interviews with hospital doctors

Intervention groups

1

Description
In the intervention group, in children over1 , the maintenance intravenous fluid with the common volume and calculated based on the Holliday-Segar formula containing 100 MEq of sodium per liter has been used and in children under 1, 50 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours.
Category
Treatment - Other

2

Description
In the control group, in children over 1 years old the maintenance intravenous fluid with the common volume and calculated through the Holliday-Segar formula containing 50 MEq of sodium per liter has been used and in children under 1 years old, 30 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Dr. Motahare Aghajani Delavar
Street address
Ghasem abad st. Shahid kiaei
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran Univercity of Medcal Sciences
Full name of responsible person
Dr. Masood Yunesian
Street address
Keshavarz st, Ghods st
City
Tehran
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, Tehran Univercity of Medcal 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
Tehran Univercity of Medcal Sciences
Full name of responsible person
Dr. Motahare Aghajani Delavar
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Ghasem abad st, Shahid Khaei
City
Tehran
Postal code
Phone
+98 21 4441 2447
Fax
Email
maghajani@razi.tums.ac.ir; aghajani_14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Univercity of Medcal Sciences
Full name of responsible person
Dr. Dariush Fahimi
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Ghasem abad st, Shahid Kiaei
City
Tehran
Postal code
Phone
+98 21 7301 3000
Fax
Email
fahimida@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Univercity of Medcal Sciences
Full name of responsible person
Dr. Motahare Aghajani Delavar
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Ghasem abad st, Shahid Kiaei st
City
Tehran
Postal code
Phone
+98 21 4441 2447
Fax
Email
maghajani@razi.tums.ac.ir; aghajani_14@yahoo.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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