Determining the Effect of Utilization of Nutrition's Guideline by nurses on Incidence and Severity of Malnutrition in ICU
Design
Clinical practice with control group, uniformity conditions apply, with parallel groups, randomized
Settings and conduct
intensive care unit of Golestan Hospital in ahwaz as an intervention group and intensive care unit of Imam Khomeini Hospital in Ahwaz as a control group
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 14 and above
2. Hospitalization in the intensive care unit up to 24 hours after admission to the hospital
3. Stay in the intensive care unit for at least 10 days (more than 10 days), feed the patient for 10 days staying in the department and participating in the project through oral nutrition or through the stomach or tube tube Gastrostomy
Intervention groups
Evaluating the training and application of ICU patients nutrition guideline to nurses and its effect on the incidence and severity of malnutrition in hospitalized patients.
Main outcome variables
The incidence of malnutrition; Severity of malnutrition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180314039097N1
Registration date:2018-10-03, 1397/07/11
Registration timing:retrospective
Last update:2018-10-03, 1397/07/11
Update count:0
Registration date
2018-10-03, 1397/07/11
Registrant information
Name
Mehdi Nik sefat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 5642
Email address
niksefat.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying nutritional guideline By nurses on Incidence And intensity of malnutrition in hospitalized patients in ICU
Public title
The Effect of using nutritional guidelines by nurses on the incidence and severity of malnutrition in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 14 and above
Admission to intensive care unit up to 24 hours after admission to the hospital
Accommodation and hospitalization in the intensive care unit for at least 10 days (more than 10 days), feeding the patient during 10 days of staying in the department and participating in the project through oral nutrition or through the stomach tube or gastrostum tube
Exclusion criteria:
A patient's request to leave the study at any time, if the patient is alert
hyperparathyroidism
Hodgkin's disease
exposure to pheochromocytoma (causes false increase in serum per-albumin levels)
use of corticosteroids or non-steroidal anti-inflammatory drugs (leading to false increases in serum per-albumin levels)
catching liver disease or severe infection
injection of protein-containing components into the patient
Severe dehydration of the patient and CVP of less than (2 cm) of water due to false increase in serum per-albumin.
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
To prevent subversion, the person who evaluates the participants on a daily basis will not be informed about the type of treatment they receive from each participant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Room 4, Ground Floor, deputy of Research and Technology Development of Ahvaz Jundishapur University of Medical Sciences, University of Ahvaz
City
ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR.AJUMS.REC.1396.993
Health conditions studied
1
Description of health condition studied
Malnutrition
ICD-10 code
E43
ICD-10 code description
Unspecified severe protein-calorie malnutrition
Primary outcomes
1
Description
Incidence of malnutrition in icu patients
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Maestricht index
Secondary outcomes
1
Description
Severity of malnutrition
Timepoint
Before the intervention and ten days after the intervention
Method of measurement
Maestricht index
Intervention groups
1
Description
intervention group: the nurses will be trained in the latest version of the ICE Patient's Feeding Guideline to identify the nutritional needs of their patients and provide the food they need. This will be done under the supervision of an ICU specialist and nutritionist. This diet is then given to patients for two weeks.
Category
Treatment - Other
2
Description
Control group: For this group only routine care is provided. The diet is routine for patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mehdi Niksefat
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3001
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Ground floor, Ahvaz University of Medical Sciences Jundishapur Health Services, University of Ahvaz, Assistant Professor of Research and Technology
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Nik sefat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ammaniyah, Loghman Ave., Socrates Street, student dormitory of shohada 3
City
Ahwaz
Province
Khouzestan
Postal code
6133994446
Phone
+98 61 3336 5642
Fax
Email
mehdi2niksefat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Nik sefat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ammaniyah, Loghman Ave., Socrates Street, student dormitory of shohada 3
City
Ahwaz
Province
Khouzestan
Postal code
6133994446
Phone
+98 61 3336 5642
Fax
Email
mehdi2niksefat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Nik sefat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ammaniyah, Loghman Ave., Socrates Street, student dormitory of shohada 3
City
Ahwaz
Province
Khouzestan
Postal code
6133994446
Phone
+98 61 3336 5642
Fax
Email
mehdi2niksefat@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Title and more details about the data/document
Statistics and the results of a general analysis of data, including the tables and charts of the study, will be published along with the conclusions of the study
When the data will become available and for how long
Start the access period 4 months after printing the results
To whom data/document is available
Data will be available to all researchers in all disciplines
Under which criteria data/document could be used
if needed, data will be provided to individuals by email.
From where data/document is obtainable
Referring to the Archives of Theses of Faculty of Nursing and Midwifery, Ahwaz University of Medical Sciences
Send an application to the email mehdiniksefat@yahoo.com
What processes are involved for a request to access data/document