Protocol summary
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Study aim
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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.
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Design
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Randomized controlled trial, double blind, parallel group, single center
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Mortality rate
Total volume removed during CRRT
Hospital admission days
Duration of staying in ICU
Length of being under mechanical ventilation
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-11-23, 1398/09/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-19, 1397/01/30
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Expected recruitment end date
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2019-04-19, 1398/01/30
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Actual recruitment start date
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2018-04-19, 1397/01/30
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Actual recruitment end date
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2019-09-21, 1398/06/30
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Trial completion date
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2019-10-27, 1398/08/05
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Scientific title
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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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Public title
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The effect of Bio-impedance Analysis in fluid management of patients on Continuous Renal Replacement Therapy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-17, 1397/01/28
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Ethics committee reference number
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IR.SBMU.MSP.REC.1397.102
Health conditions studied
1
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Description of health condition studied
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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
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ICD-10 code
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N17-N19
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ICD-10 code description
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Acute kidney failure
2
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Description of health condition studied
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Fluid overload:excess fluid in intracellular or extracellular compartments
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ICD-10 code
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E87.7
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ICD-10 code description
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Fluid overload
Primary outcomes
1
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Description
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The water content lean body mass
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Timepoint
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After 72 hours of undergoing CRRT with excluding the time in interruption periods between CRRT sessions
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Method of measurement
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Records of bioimpedance analyser instrument
Secondary outcomes
1
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Description
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Duration of ICU admission
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Timepoint
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After discharge from the hospital.
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Method of measurement
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Patient's medical files
2
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Description
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Duration of hospital admission
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Timepoint
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After discharge from the hospital.
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Method of measurement
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Patient's medical files
3
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Description
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time duration of spending under mechanical ventilation
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Timepoint
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After discharge from the hospital.
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Method of measurement
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Patient's medical files
4
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Description
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Urine output
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Timepoint
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every 8 hors during CRRT
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Method of measurement
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use of scaled containers
5
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Description
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Mortality rate
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Timepoint
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At 10th , 30th and 60th day of the study
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Method of measurement
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Patient are followed for mortality up to 60 days . At the 10th , 30th and 6th day , the mortality is recorded
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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Control group: In patients of this group the volume of fluid removal with ultrafiltration during CRRT is determined based on clinical findings.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All individual non-identified participant data
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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For people working in academic institutions
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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The applicants can get the documents through the email, f_rashid@sbmu.ac.ir
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What processes are involved for a request to access data/document
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The process of evaluating the requests and sending these documents will take about 3 months.
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Comments
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