Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000543280
Ethics application status
Approved
Date submitted
9/01/2018
Date registered
11/04/2018
Date last updated
11/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of intraabdominal hypertension and abdominal compartment syndrome in pediatric intensive care units in Ukraine.
Scientific title
Incidence of intraabdominal hypertension and abdominal compartment syndrome in pediatric intensive care units in Ukraine: a prospective multicentre observational study.
Secondary ID [1] 293741 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraabdominal hypertension 306107 0
Abdominal compartment syndrome 306108 0
Condition category
Condition code
Oral and Gastrointestinal 305236 305236 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 305703 305703 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Days
Description of intervention(s) / exposure
Number of children with intraabdominal hypertension and abdominal compartment syndrome in 50 PICUs in Ukraine will be registered. These conditions will be registered in all children who are hospitalized in PICU on a certain day in 2018 year. Responsible person of each PICU will have 1 certain day to register these conditions and second day to send information to investigators. Beside this underlying conditions, ventilation, hemodynamics, diuresis etc. will be analyzed. After data collection conclusions about incidence and its dependance on other variables will be made.
Intervention code [1] 299992 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304389 0
Incidence of intraabdominal hypertension in children in PICU.
Number of patients with intraabdominal pressure above 10 mm Hg will be registered. Data will be collected from Google forms which will be filled by staff on site. Then this number will be divided by general number of patient in PICU and incidence of intraabdominal hypertension (in %) will be calculated.
Timepoint [1] 304389 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Primary outcome [2] 304390 0
Incidence of abdominal compatrment syndrome in children in PICU.
Number of patients with intraabdominal pressure above 10 mm Hg with new or worsening organ dysfunction will be registered. Data will be collected from Google forms which will be filled by staff on site. Then this number will be divided by general number of patient in PICU and incidence of abdominal compatrment syndrome (in %) will be calculated.
Timepoint [2] 304390 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [1] 341795 0
Hypothermia as a risk factor for IAH and ACS. Will be assessed by registration of body temperature below 36 Celsius. Data will be collected from Google forms which will be filled by staff on site.
Timepoint [1] 341795 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [2] 343325 0
Acidosis as a risk factor for IAH and ACS. Will be assessed by blood gases analysis.
Timepoint [2] 343325 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [3] 343326 0
Mechanical ventilation as a risk factor for IAH and ACS. Will be assessed by registration of the fact of MV. Data will be collected from Google forms which will be filled by staff on site.
Timepoint [3] 343326 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [4] 343327 0
Shock as a risk factor for IAH and ACS. Will be assessed by registration of hemodynamic values, plasma lactate level above 4 mmol/l
Timepoint [4] 343327 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [5] 343328 0
Sepsis as a risk factor for IAH and ACS. Will be assessed by registration of infection, SIRS criteria and procalcitonin level above 0.5 ng/ml. Data will be collected from Google forms which will be filled by staff on site.
Timepoint [5] 343328 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [6] 343329 0
Aggressive fluid resuscitation as a risk factor for IAH and ACS. Will be assessed by positive hydrobalance. Data will be collected from Google forms which will be filled by staff on site.
Timepoint [6] 343329 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.
Secondary outcome [7] 343330 0
Gastrointestinal dysfunction as a risk factor for IAH and ACS. Will be assessed by registration of peristaltic movements (auscultation), stool presence, feeding tolerance (intolerance will be registered when regurgitaton through nasogastric tube will be above 50% of feeding volume). Data will be collected from Google forms which will be filled by staff on site. This secondary outcome is composite.
Timepoint [7] 343330 0
Each PICU will have 1 certain day through period of investigation on which staff will collect data and transfer it to investigators. On that day all children hospitalized in this PICU will be assessed.

Eligibility
Key inclusion criteria
Children hospitalized in PICU
Minimum age
1 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2018
Date of last participant enrolment
Anticipated
1/03/2019
Actual
Date of last data collection
Anticipated
4/03/2019
Actual
Sample size
Target
300
Accrual to date
11
Final
Recruitment outside Australia
Country [1] 9475 0
Ukraine
State/province [1] 9475 0

Funding & Sponsors
Funding source category [1] 298353 0
Hospital
Name [1] 298353 0
Lviv Regional Children's Clinic Hospital
Country [1] 298353 0
Ukraine
Primary sponsor type
Hospital
Name
Lviv Regional Children's Clinic Hospital
Address
Lysenka 31, Lviv 79008
Country
Ukraine
Secondary sponsor category [1] 297477 0
None
Name [1] 297477 0
Address [1] 297477 0
Country [1] 297477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299348 0
Lviv Regional Children’s Hospital Ethics Committee
Ethics committee address [1] 299348 0
Lysenka str. 31, Liviv 79008
Ethics committee country [1] 299348 0
Ukraine
Date submitted for ethics approval [1] 299348 0
04/12/2017
Approval date [1] 299348 0
09/01/2018
Ethics approval number [1] 299348 0
1-1-2018

Summary
Brief summary
Intraabdominal hypertension (IAH) and abdominal compartment syndrome (ACS) can lead to morbidity and mortality if untreated. Conditions that contribute to IAH and ACS development are decreased abdominal wall compliance (hernia repair, burns), increased intraabdominal volume (bowel obstruction, ileus, ascites, tumor), capillary leak (aggressive fluid resuscitation in sepsis and trauma), etc. Incidence and risk factors of IAH and ACS in children are not studied well. Beside this intraabdominal pressure monitoring and prompt treatment of IAH and ACS are not standard care in PICUs. We plan to study incidence and risk factors of IAH and ACS in critically ill children and to draw attention to this problem among intensivists in Ukraine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80138 0
Dr Andrew Albokrinov
Address 80138 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 80138 0
Ukraine
Phone 80138 0
+380672867103
Fax 80138 0
+380322759467
Email 80138 0
[email protected]
Contact person for public queries
Name 80139 0
Valentyna Perova-Sharonova
Address 80139 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 80139 0
Ukraine
Phone 80139 0
+380673971913
Fax 80139 0
+380322759467
Email 80139 0
[email protected]
Contact person for scientific queries
Name 80140 0
Andrew Albokrinov
Address 80140 0
Lviv Regional Children’s Clinic Hospital, Lysenka str. 31, Lviv 79008, Ukraine.
Country 80140 0
Ukraine
Phone 80140 0
+380672867103
Fax 80140 0
+380322759467
Email 80140 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.