Clinical evaluation of applying bio-impedance analysis as a guide to detect the appropriate ultrafiltration rate in patients undergoing continuous renal replacement therapy
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Primary outcomes
#1
Mortality rate
The water content lean body mass
Mortality rateThe water content lean body mass
میزان مرگ و میر
میزان مایع توده ی بدون چربی بدن
میزان مرگ و میرمایع توده ی بدون چربی بدن
At 10th , 30th and 60th day of the study
After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions
At 10th , 30th and 60th dayAfter 72 hours of undergoing CRRT with excluding the studytime in interruption periods between CRRT sessions
در روزهای 10 ، 30 و 60 مطالعه
بعد از ۷۲ ساعت از قرار گرفتن تحت CRRT با حذف وقفه ها در فواصل جلسات CRRT
بعد از ۷۲ ساعت از قرار گرفتن تحت CRRT با حذف وقفه ها در روزهای 10 ، 30 و 60 مطالعهفواصل جلسات CRRT
Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded.
Records of bioimpedance analyser instrument
Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded.Records of bioimpedance analyser instrument
بیماران تا ۶۰ روز بعد از ترخیص از نظر مرگ و میر پیگیری می شوند. در روزهای 10 و 30 و 60 مرگ و میر ثبت می گردد.
گزارش های ثبت شده توسط دستگاه بیوایمپدانس
بیماران تا ۶۰ روز بعد از ترخیص از نظر مرگ و میر پیگیری می شوند. در روزهای 10 و 30 و 60 مرگ و میرگزارش های ثبت می گردد.شده توسط دستگاه بیوایمپدانس
#2
The water content lean body mass
empty
The water content lean body mass
میزان مایع توده ی بدون چربی بدن
empty
میزان مایع توده ی بدون چربی بدن
After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions
empty
After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions
بعد از ۷۲ ساعت از قرار گرفتن تحت CRRT با حذف وقفه ها در فواصل جلسات CRRT
empty
بعد از ۷۲ ساعت از قرار گرفتن تحت CRRT با حذف وقفه ها در فواصل جلسات CRRT
Records of bioimpedance analyser instrument
empty
Records of bioimpedance analyser instrument
گزارش های ثبت شده توسط دستگاه بیوایمپدانس
empty
گزارش های ثبت شده توسط دستگاه بیوایمپدانس
Secondary outcomes
#1
empty
Mortality rate
Mortality rate
empty
میزان مرگ و میر
میزان مرگ و میر
empty
At 10th , 30th and 60th day of the study
At 10th , 30th and 60th day of the study
empty
در روزهای 10 ، 30 و 60 مطالعه
در روزهای 10 ، 30 و 60 مطالعه
empty
Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded
Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded
empty
بیماران تا ۶۰ روز بعد از ترخیص از نظر مرگ و میر پیگیری می شوند. در روزهای 10 و 30 و 60 مرگ و میر ثبت می گردد.
بیماران تا ۶۰ روز بعد از ترخیص از نظر مرگ و میر پیگیری می شوند. در روزهای 10 و 30 و 60 مرگ و میر ثبت می گردد.
Protocol summary
Study aim
Acute kidney injury (AKI) frequently occurs in intensive care units and increases the mortality rate, especially when the patients are over-hydrated. However, clinical and laboratory findings have poor sensitivity to detect volume overload in critically ill patients. There is no consensus about the way to determine appropriate ultrafiltration (UF) volume in patients on continuous renal replacement therapy (CRRT). In this study, we evaluate the benefits of fluid management based on bio-impedance analysis (BIA) in patients receiving CRRT.
Design
Randomized controlled trial, double blind, parallel group, single center
Settings and conduct
Participants are assigned to case and control groups by using a software generated table of random numbers. The results of bio-impedance-analysis are applied in management of patients in study group. Patients and outcome analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Admission to the intensive care unit of Masih Daneshvari hospital and
receiving CRRT for AKI
Exclusion criteria:
The age less than 18 years old
Stage 4 or 5 of chronic kidney disease
Kidney transplantation
Limb amputation
Cardiopulmonary resuscitation within 24 hours before CRRT
Death during the first 24 hours of CRRT
Intervention groups
The body weights and compositions are measured by a bed scale and a BioScan-916 analyzer at the start of CRRT and every 8 hours thereafter. Hydration status was estimated by clinical findings in control group and the water content of lean body mass or the distance from the major axis of tolerance ellipse in bioimpedance vector analysis (BIVA) in study group. The UF rate was set and changed during CRRT based on the different protocols in each group.
Main outcome variables
Mortality rate
Total volume removed during CRRT
Hospital admission days
Duration of staying in ICU
Length of being under mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181108041595N1
Registration date:2019-11-23, 1398/09/02
Registration timing:retrospective
Last update:2021-11-27, 1400/09/06
Update count:1
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Farin Rashid Farokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 3282
Email address
f_rashid@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2018-04-19, 1397/01/30
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-10-27, 1398/08/05
Scientific title
Clinical evaluation of applying bio-impedance analysis as a guide to detect the appropriate ultrafiltration rate in patients undergoing continuous renal replacement therapy
Public title
The effect of Bio-impedance Analysis in fluid management of patients on Continuous Renal Replacement Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admission to the intensive care units of Masih Daneshvari Hospital during the study period
Occurring of acute kidney injury
Requirement of continuous Renal Replacement Therapy
Age of more than 18 years
Exclusion criteria:
History of of stage 4 and 5 of chronic kidney disease
History of kidney transplantation
Cardiorespiratory resuscitation within 24 hours before the start of Renal Replacement Therapy
Patient death before 24 hours of starting first Continuous Renal Replacement Therapy
History of limb amputation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
65
More than 1 sample in each individual
Number of samples in each individual:
1
Each patients contribute one sample to the trial
Actual sample size reached:
65
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible patients admitted to the ICU during the study period are included. The method of randomization is simple and patients are assigned to case or control groups by using a software generated table of random numbers. Bio-impedance analysis is performed for all participant by the operator every 8 hours during performing CRRT. In order to carry out allocation concealment, the patient code is sent to a third party who has the table of random number to decide whether this code directs patient to the study or control group. Then he inform the principal investigator about the patient group. The investigator will apply the results of bio-impedance analysis in determining UF volume during CRRT only in case group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bio-impedance analysis is performed for all patients and our participants or their guardians are not awarded of the study group they are assigned to. Our data analyzer will analyze the data of two groups without having any other information about the aim of the study and case or control groups. In the study design, the results of bio-impedance analysis should be consider in the order of ultrafiltration volume is only in participants directed to study group. So, the main investigator can not be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
AKI- increase in serum creatinine by at least 0.3 mg/dl within 48 hours or 1.5 times baseline within prior 7 days or urine volume less than 0.5 ml/kg/hour for six hours
ICD-10 code
N17-N19
ICD-10 code description
Acute kidney failure
2
Description of health condition studied
Fluid overload:excess fluid in intracellular or extracellular compartments
ICD-10 code
E87.7
ICD-10 code description
Fluid overload
Primary outcomes
1
Description
The water content lean body mass
Timepoint
After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions
Method of measurement
Records of bioimpedance analyser instrument
Secondary outcomes
1
Description
Duration of ICU admission
Timepoint
After discharge from the hospital.
Method of measurement
Patient's medical files
2
Description
Duration of hospital admission
Timepoint
After discharge from the hospital.
Method of measurement
Patient's medical files
3
Description
time duration of spending under mechanical ventilation
Timepoint
After discharge from the hospital.
Method of measurement
Patient's medical files
4
Description
Urine output
Timepoint
every 8 hors during CRRT
Method of measurement
use of scaled containers
5
Description
Mortality rate
Timepoint
At 10th , 30th and 60th day of the study
Method of measurement
Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded
Intervention groups
1
Description
Intervention group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on the results of bio-impedance analysis.
Category
Treatment - Devices
2
Description
Control group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on clinical findings.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farin Rashid Farokhi
Street address
Daarabad ,Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2602
Fax
Email
f_rashid@sbmu.ac.ir
Web page address
http://en.nritld.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parissa Farnia
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19575154
Phone
+98 21 2712 2000
Email
farnia@theaasm.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All individual non-identified participant data
When the data will become available and for how long
6 months after publication
To whom data/document is available
For people working in academic institutions
Under which criteria data/document could be used
Further sharing of the data should be with permission of original investigators
The use of data for purposes other than those originally proposed in the application is prohibited
From where data/document is obtainable
The applicants can get the documents through the email, f_rashid@sbmu.ac.ir
What processes are involved for a request to access data/document
The process of evaluating the requests and sending these documents will take about 3 months.