Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000753358
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
22/05/2017
Date last updated
12/01/2023
Date data sharing statement initially provided
12/01/2023
Date results information initially provided
12/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the ability to achieve negative water balance in children undergoing continuous renal replacement therapy (CRRT) and its possible relation to mortality.
Scientific title
A retrospective cohort study of the ability to achieve negative water balance in critically ill children undergoing CRRT and its possible relation to mortality.
Secondary ID [1] 291639 0
Nil
Universal Trial Number (UTN)
U1111-1195-2230
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill children 302776 0
Acute kidney injury 302777 0
Condition category
Condition code
Renal and Urogenital 302285 302285 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A retrospective observational trial where critically ill children subjected to acute kidney injury undergoing continuous renal replacement therapy (CRRT) are characterized. Patients are identified in the ICU database. The patients are primary studied to elucidate if ability to achieve or not to achieve negative water balance within the first 72 hours after CRRT is initiated is associated with increased mortality rate. The patients are observed during the entire PICU stay.
Intervention code [1] 297722 0
Not applicable
Comparator / control treatment
Survivors will be matched to non-survivors for potential confounders: age, gender, comorbidity, degree of fluid overload, degree of multiple organ failure and circuit life span.
Control group
Active

Outcomes
Primary outcome [1] 301694 0
Occurrence of water imbalance defined as inability to achieve cumulative negative water balance within 72 hours after CRRT initiation as reported in medical records and its possible association with increased mortality.
Timepoint [1] 301694 0
Ability to acheive negative water balance within 72 hours after CRRT initiation (yes or no).
Primary outcome [2] 302082 0
Mortality
Timepoint [2] 302082 0
Mortality occurring during PICU stay.
Secondary outcome [1] 333582 0
Fluid overload (FO) defined as cumulative FO from admission until the initiation of CRRT. FO will be calculated as: FO % = ml fluid in - fluid out from admission to the PICU divided by admission weight.
Timepoint [1] 333582 0
FO occurring from PICU admission until CRRT initiation.
Secondary outcome [2] 333583 0
Circuit life span defined as the median survival time of dialysis filter
Timepoint [2] 333583 0
Circuit life span during CRRT.
Secondary outcome [3] 333584 0
The severity of illness (6 organ failures: neurological, respiratory, circulatory, renal, immunological and liver) measured at admission to the PICU by medical records
Timepoint [3] 333584 0
At admission to the PICU.

Eligibility
Key inclusion criteria
Critically ill children (age newborns up to 18 year) subjected to acute kidney injury and undergoing continuous renal replacement therapy (CRRT).
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All critically ill children not undergoing CRRT

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Student’s t-test, Wilson matched pair test, One-way ANOVA followed by Tukey’s post hoc test, will be used when applicable using GraphPad Prism 5 (GraphPad Software, Inc.7825 Fay Avenue, Suite 230 La Jolla, CA 92037 USA).
Potential predictors of mortality (where water balance during the first 72 hours after CRRT initiation is the primary variable) will be analyzed by univariate logistic regression followed by step-wise backward multiple logistic regression using the software NCSS 2007, Kaysville, Utah. Only factors with p < 0.1 will be used in the multiple logistic regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
30/09/2017
Actual
30/09/2017
Date of last data collection
Anticipated
30/09/2017
Actual
30/09/2017
Sample size
Target
80
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 8783 0
Sweden
State/province [1] 8783 0
Stockholm

Funding & Sponsors
Funding source category [1] 296134 0
Hospital
Name [1] 296134 0
Karolinska University Hospital
Country [1] 296134 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Barn-PMI. Karolinska University Hospital. 17176 Stockholm. Sweden.
Country
Sweden
Secondary sponsor category [1] 295031 0
None
Name [1] 295031 0
Not applicable
Address [1] 295031 0
Not applicable
Country [1] 295031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297386 0
Ethics committee of Stockholm Sweden
Ethics committee address [1] 297386 0
Ethics committee of Stockholm Sweden. Wiederstromska huset. Tomtebodavagen 18 A. 17165 Solna.
Ethics committee country [1] 297386 0
Sweden
Date submitted for ethics approval [1] 297386 0
12/07/2013
Approval date [1] 297386 0
13/08/2013
Ethics approval number [1] 297386 0
2013/1207-31/1

Summary
Brief summary
Acute kidney injury is common in the PICU and is associated with fluid overload. Increasing degrees of fluid overload at the time of CRRT initiation is associated with increased mortality. It is unknown if the ability to achieve negative water balance is related to outcome, circuit life span and infectious control in children.
The main purpose of this retrospective cohort study is to evaluate the association between possible inability to achieve negative water balance within 72 hours after CRRT initiation in critically ill children and mortality. We will retrospectively include all patients subjected to acute kidney injury and undergoing CRRT admitted to our PICU. The period of inclusion is set from 2009 until 2016.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73882 0
Dr Urban Flaring
Address 73882 0
Barn-PMI
Eugeniavagen 23
Karolinska University Hospital
17176 Stockholm
Country 73882 0
Sweden
Phone 73882 0
+46708763900
Fax 73882 0
Email 73882 0
[email protected]
Contact person for public queries
Name 73883 0
Dr Urban Flaring
Address 73883 0
Barn-PMI
Eugeniavagen 23
Karolinska University Hospital
17176 Stockholm
Country 73883 0
Sweden
Phone 73883 0
+46708763900
Fax 73883 0
Email 73883 0
[email protected]
Contact person for scientific queries
Name 73884 0
Dr Urban Flaring
Address 73884 0
Barn-PMI
Eugeniavagen 23
Karolinska University Hospital
17176 Stockholm
Country 73884 0
Sweden
Phone 73884 0
+46708763900
Fax 73884 0
Email 73884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18030Ethical approval  [email protected] Ethical approval will be given on request via emai... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Andersson A, Norberg Å, Broman M, Mårtensson J, Fl... [More Details]
Plain language summaryNo Primary research question: to investigate if the a... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFluid balance after continuous renal replacement therapy initiation and outcome in paediatric multiple organ failure.2019https://dx.doi.org/10.1111/aas.13389
N.B. These documents automatically identified may not have been verified by the study sponsor.